A Phase 1 interventional study of CTH522-CAF01 IM and CTH522-CAF09b IM in Trachoma, sponsored by Statens Serum Institut. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Statens Serum Institut · Phase 1, Interventional, and Prevention
CHLM-02 was a phase I, double-blind, randomized, placebo-controlled trial of the chlamydia vaccine CTH522. 65 trial participants were randomized into 12 groups and six cohorts (A1 to F2). Cohorts A to E received three intramuscular (IM) injections of CTH522 (Day 0, 28, and 112). Cohorts A to D received CTH522 adjuvanted with Cationic Adjuvant Formulation (CAF®) 01 IM in two doses (85µg [A to C] or 15µg [D]). Cohort E received 85µg CTH522 adjuvanted with CAF®09b. Cohorts B and C received unadjuvanted CTH522 boost via the topic ocular (TO) or intradermal (ID) route, respectively, jointly with the second and third IM vaccinations. Cohort F received placebo. The effect of mucosal recall on eye immunity with TO CTH522 or placebo was assessed Day 140.
This trial was a phase I, double-blind, parallel, randomised, and placebo-controlled trial of the chlamydia vaccine CTH522 in healthy adults.
It was planned to randomize 66 subjects but only 65 subjects were randomized. Cohorts A-D investigated CTH522-CAF01 administered IM in two doses (85 mcg and 15 mcg). Cohort E investigated CTH522-CAF09b administered IM in one dose (85 mcg). Cohort F was the placebo group. The enrolled subjects were to complete 12 trial visits. All subjects in the active cohorts (cohort A-E) were to receive three IM injections of the adjuvanted CTH522 and some (cohort B and C) were to receive the non-adjuvanted CTH522 via the TO or ID route (given at the same time as the 2nd and 3rd IM vaccinations). All active cohorts were to receive TO administration as a boost at Day 140 of either the non-adjuvanted CTH522 (12 mcg in each eye) or placebo.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 65 is below the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →Statens Serum Institut is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
IC1: Healthy males and females between 18-45 years old on the day of the first vaccination.
IC2: Has been properly informed about the trial and signed the consent form.
IC3: Is willing and likely to comply with trial procedures.
IC4: Is prepared to grant authorised persons access to his/her trial-related medical record.
IC5: Is willing to use acceptable measures during the trial (two weeks before and two weeks after the trial). Heterosexually active female capable of becoming pregnant must agree to use hormonal contraception, intrauterine device, intrauterine hormone releasing system, or to complete abstinence from at least two weeks before the first vaccination until at least two weeks after the last. Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), withdrawal and progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, are not acceptable methods of contraception.
Exclusion criteria:
EX1: Is positive for C. trachomatis via urine PCR or has a known history of C. trachomatis.
EX2: Is positive for gonorrhoea via urine PCR test, or , /C, syphilis via blood tests.
EX3: Has a significant active disease such as cardiac, liver, immunological, neurological, psychiatric, or abnormality of haematological or biochemical parameters.
EX4: Has ≥ 35 kg/m2.
EX5: Is currently participating in another clinical trial with an or noninvestigational drug or device, or was treated with an investigational drug within 28 days before the first vaccination.
EX6: Has received, or plans to receive, any immunisation within 14 days of the start of the trial or during the trial immunisations.
EX7: Is currently receiving treatment with systemic agents. Topical are allowed unless applied to the IM or ID injection site.
EX8: Has a condition which in the opinion of the investigator is not suitable for participation in the trial.
EX9: Is known or confirmed to have an allergy to any of the vaccine constituents.
EX10: Is unable to refrain from the use of contact lenses. Contact lenses should be avoided two days before TO administration and for seven days later (longer if any ongoing local eye AE).
EX11: Has any evident ocular disease upon ophthalmoscopic exam at screening or any medical history of ocular disease that, in the opinion of the investigator, may impact the subject's participation in the trial.
EX12: Is pregnant (positive pregnancy test) or breastfeeding or not willing to use during the trial.
EX13: Has confirmed a history of pelvic inflammatory disease or significant gynaecological diseases.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort A received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort A1 receives placebo at Day 28, 112, and 140, while cohort A2 received placebo at Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140.
Biological: CTH522-CAF01 IM · Biological: CTH522 TO · Biological: Placebo (Saline)
Cohort B received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140.
Biological: CTH522-CAF01 IM · Biological: CTH522 TO · Biological: Placebo (Saline)
Cohort C received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort C1 received ID vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort C2 received the same for Day 28 and 112, but TO CTH522 boost at Day 140.
Biological: CTH522-CAF01 IM · Biological: CTH522 ID · Biological: CTH522 TO · Biological: Placebo (Saline)
Cohort D received three IM vaccination of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort D1 received TO placebo given on Day 28, 112, and 140, while cohort D2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
Biological: CTH522-CAF01 IM · Biological: CTH522 TO · Biological: Placebo (Saline)
Cohort E received three IM vaccination of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). This cohort was divided into two groups: Cohort E1 received TO placebo given on Day 28, 112, and 140, while cohort E2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140.
Biological: CTH522-CAF09b IM · Biological: CTH522 TO · Biological: Placebo (Saline)
Cohort F received three IM vaccinations of placebo in form of 0.9% NaCl saline (Day 0, 28, and 112).This cohort was divided into two groups: Cohort F1 received TO placebo given on Day 28, 112, and 140, while cohort F2 received ID placebo given on Day 28 and 112 and TO placebo on Day 140.
Biological: Placebo (Saline)
On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF09b. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
24 mcg CTH522 given ID is in the non-dominant deltoid muscle. ID with a 1 mL syringe via a 26-28 gauge needle using a NanoPass device or similar. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
24 mcg CTH522 (12 mcg in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
Placebo only given as IM, ID and TO.
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Time frame: Visit 2 (Day 0) plus 14 Days
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Time frame: Visit 4 (Day 28) plus 14 Days
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Time frame: Visit 7 (Day 112) plus 14 Days
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Time frame: Visit 4 (Day 28) plus 14 Days
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Time frame: Visit 7 (Day 112) plus 14 Days
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Time frame: Visit 9 (Day 140) plus 14 Days
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Time frame: Visit 2 (Day 0) plus 14 Days
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Time frame: Visit 4 (Day 28) plus 14 Days
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Time frame: Visit 7 (Day 112) plus 14 Days
Immunogenicity (4-fold Increase From Baseline)
Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Time frame: Day 14, 28, 42, 56, 112, 126, 140, 154, 238
Immunogenicity (10-fold Increase From Baseline)
Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Time frame: Day 14, 28, 42, 56, 112, 126, 140, 154, 238
| Milestone | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01+ TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 2 | 9 | 3 | 9 | 3 | 9 | 3 | 9 | 3 | 9 | 3 | 3 |
| Completed | 2 | 8 | 2 | 9 | 3 | 8 | 2 | 9 | 3 | 8 | 3 | 3 |
| Not completed | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 |
Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection site pain | 2 | 8 | 3 | 9 | 2 | 9 | 3 | 9 | 3 | 9 | 0 | 1 |
| Injection site warmth | 0 | 1 | 2 | 3 | 1 | 4 | 0 | 2 | 1 | 2 | 0 | 1 |
| Injection site swelling | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 0 | 0 |
| Injection site erythema | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Injection site pruritus | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection site pain | 2 | 8 | 2 | 9 | 3 | 9 | 2 | 9 | 3 | 6 | 1 | 2 |
| Injection site warmth | 0 | 3 | 1 | 3 | 0 | 2 | 0 | 2 | 0 | 1 | 1 | 1 |
| Injection site erythema | 0 | 0 | 0 | 0 | 3 | 4 | 0 | 0 | 0 | 2 | 0 | 1 |
| Injection site pruritus | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 2 | 0 | 1 | 0 | 0 |
| Injection site swelling | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 3 | 0 | 1 |
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection site pain | 1 | 6 | 2 | 8 | 2 | 8 | 1 | 7 | 2 | 8 | 2 | 0 |
| Injection site erythema | 0 | 0 | 0 | 2 | 3 | 6 | 0 | 1 | 1 | 3 | 1 | 0 |
| Injection site warmth | 0 | 2 | 1 | 1 | 1 | 5 | 0 | 2 | 0 | 3 | 1 | 1 |
| Injection site swelling | 0 | 1 | 1 | 0 | 2 | 3 | 1 | 1 | 0 | 3 | 0 | 0 |
| Injection site pruritus | 0 | 1 | 0 | 2 | 1 | 3 | 0 | 0 | 0 | 1 | 0 | 0 |
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ocular discomfort | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
| Lacrimation increased | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Ocular hyperaemia | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Swelling of eyelid | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ocular discomfort | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Ocular hyperaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Lacrimation increased | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ocular discomfort | 0 | 2 | 0 | 3 | 0 | 1 | 1 | 0 | 0 | 3 | 1 | 0 |
| Lacrimation increased | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 1 |
| Ocular hyperaemia | 0 | 0 | 0 | 2 | 0 | 1 | 1 | 1 | 0 | 2 | 1 | 0 |
| Swelling of eyelid | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Myalgia | 0 | 1 | 0 | 1 | 2 | 1 | 1 | 1 | 2 | 0 | 0 | 0 |
| Chills | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Pyrexia | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Myalgia | 0 | 3 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Chills | 0 | 1 | 0 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Rash | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Myalgia | 0 | 1 | 0 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 0 | 0 |
| chills | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 1 | 2 | 0 | 0 |
Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 14 | 0 | 6 | 2 | 7 | 2 | 7 | 1 | 2 | 3 | 7 | 0 | 0 |
| Day 28 | 0 | 8 | 1 | 6 | 2 | 6 | 2 | 2 | 3 | 6 | 0 | 0 |
| Day 42 | 2 | 8 | 2 | 9 | 3 | 9 | 3 | 9 | 3 | 8 | 0 | 0 |
| Day 56 | 2 | 8 | 2 | 9 | 3 | 8 | 3 | 9 | 3 | 8 | 0 | 0 |
| Day 112 | 1 | 8 | 2 | 9 | 3 | 9 | 2 | 9 | 3 | 8 | 0 | 0 |
| Day 126 | 2 | 8 | 2 | 9 | 3 | 8 | 2 | 9 | 3 | 8 | 0 | 0 |
| Day 140 | 2 | 8 | 2 | 9 | 3 | 8 | 2 | 9 | 3 | 8 | 0 | 0 |
| Day 154 | 2 | 8 | 2 | 9 | 3 | 8 | 2 | 9 | 3 | 8 | 0 | 0 |
| Day 238 | 2 | 8 | 2 | 9 | 3 | 7 | 2 | 9 | 3 | 8 | 0 | 0 |
Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
| Participants | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 14 | 0 | 5 | 1 | 5 | 2 | 3 | 0 | 0 | 3 | 6 | 0 | 0 |
| Day 28 | 0 | 5 | 1 | 5 | 2 | 4 | 1 | 1 | 3 | 6 | 0 | 0 |
| Day 42 | 1 | 8 | 2 | 9 | 3 | 9 | 3 | 8 | 3 | 8 | 0 | 0 |
| Day 56 | 1 | 8 | 2 | 9 | 3 | 8 | 3 | 9 | 3 | 8 | 0 | 0 |
| Day 112 | 1 | 8 | 2 | 9 | 3 | 9 | 2 | 8 | 3 | 8 | 0 | 0 |
| Day 126 | 2 | 8 | 2 | 9 | 3 | 8 | 2 | 9 | 3 | 8 | 0 | 0 |
| Day 140 | 2 | 8 | 2 | 9 | 3 | 8 | 2 | 9 | 3 | 8 | 0 | 0 |
| Day 154 | 2 | 8 | 2 | 9 | 3 | 8 | 2 | 9 | 3 | 8 | 0 | 0 |
| Day 238 | 1 | 8 | 2 | 9 | 3 | 7 | 2 | 8 | 3 | 8 | 0 | 0 |
Collected over Up to 238 days after first vaccination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Cohort F1 IM Placebo + TO Placebo | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FatigueGeneral disorders | 2/2 | 3/9 | 1/3 | 0/9 | 0/3 | 4/9 | 2/3 | 2/9 | 0/3 | 1/9 | 1/3 | 0/3 |
| Injection site erythemaGeneral disorders | 0/2 | 1/9 | 0/3 | 2/9 | 3/3 | 8/9 | 0/3 | 1/9 | 1/3 | 4/9 | 1/3 | 1/3 |
| Injection site painGeneral disorders | 2/2 | 9/9 | 3/3 | 9/9 | 3/3 | 9/9 | 3/3 | 9/9 | 3/3 | 9/9 | 2/3 | 2/3 |
| Lacrimation increasedEye disorders | 0/2 | 1/9 | 0/3 | 3/9 | 0/3 | 1/9 | 1/3 | 1/9 | 0/3 | 0/9 | 2/3 | 1/3 |
| Ocular discomfortEye disorders | 0/2 | 2/9 | 0/3 | 3/9 | 0/3 | 1/9 | 1/3 | 0/9 | 0/3 | 3/9 | 2/3 | 1/3 |
| Injection site pruritusGeneral disorders | 0/2 | 1/9 | 0/3 | 2/9 | 2/3 | 5/9 | 0/3 | 2/9 | 0/3 | 2/9 | 0/3 | 0/3 |
| Injection site swellingGeneral disorders | 0/2 | 1/9 | 1/3 | 0/9 | 2/3 | 3/9 | 1/3 | 1/9 | 0/3 | 4/9 | 0/3 | 1/3 |
| Injection site warmthGeneral disorders | 0/2 | 4/9 | 2/3 | 4/9 | 1/3 | 6/9 | 0/3 | 4/9 | 1/3 | 5/9 | 2/3 | 1/3 |
| Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders | 0/2 | 0/9 | 0/3 | 0/9 | 0/3 | 0/9 | 0/3 | 1/9 | 2/3 | 0/9 | 0/3 | 0/3 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/2 | 3/9 | 1/3 | 2/9 | 2/3 | 3/9 | 1/3 | 2/9 | 2/3 | 2/9 | 0/3 | 0/3 |
| Age, Categorical(Participants) | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 9 | 3 | 9 | 3 | 9 | 3 | 9 | 3 | 9 | 3 | 3 | 65 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 22.0 ± 1.4 | 26.9 ± 6.4 | 21.7 ± 2.1 | 28.4 ± 7.3 | 32.3 ± 6.1 | 22.4 ± 2.4 | 25.7 ± 9 | 26.8 ± 5.6 | 31.7 ± 8.5 | 30.1 ± 9.9 | 24.7 ± 5.5 | 25.0 ± 5.3 | 26.8 ± 6.8 |
| Sex: Female, Male(Participants) | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 5 | 1 | 1 | 1 | 6 | 2 | 5 | 3 | 5 | 2 | 3 | 34 |
| Male | 2 | 4 | 2 | 8 | 2 | 3 | 1 | 4 | 0 | 4 | 1 | 0 | 31 |
| Race/Ethnicity, Customized(participants) | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| White | 1 | 6 | 3 | 4 | 3 | 6 | 3 | 6 | 1 | 7 | 3 | 3 | 46 |
| Asian | 0 | 1 | 0 | 1 | 0 | 3 | 0 | 1 | 1 | 1 | 0 | 0 | 8 |
| Black or African American | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 3 |
| Other | 1 | 1 | 0 | 4 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 8 |
| Region of Enrollment(participants) | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United Kingdom | 2 | 9 | 3 | 9 | 3 | 9 | 3 | 9 | 3 | 9 | 3 | 3 | 65 |
| BMI(kg/m2) | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 20.70 ± 3.96 | 24.78 ± 3.02 | 23.73 ± 2.25 | 22.62 ± 3.58 | 26.23 ± 2.55 | 23.63 ± 2.41 | 24.70 ± 1.55 | 23.13 ± 1.67 | 21.70 ± 0.92 | 24.11 ± 3.55 | 24.37 ± 3.20 | 22.77 ± 0.55 | 23.64 ± 2.78 |
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Statens Serum Institut