A Phase 3 interventional study of PXVX0200 and Placebo in Cholera, sponsored by Bavarian Nordic. Completed at 16 sites in United States. Open to participants aged 46 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Bavarian Nordic · Phase 3, Interventional, and Prevention
Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.
Demonstrate that seroconversion by classical Inaba vibriocidal antibody at Day 11 in older adults ages 46-64 years (inclusive) was non inferior to seroconversion at Day 11 in younger adults ages 18-45 years following vaccination with PXVX0200.
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
This study's enrollment of 398 is above the median of 262 across 72 interventional studies indexed under Cholera.
Browse Cholera studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
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.
Exclusion Criteria:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
PXVX0200 Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension
Biological: PXVX0200
Placebo physiological saline
Biological: Placebo
This arm consists of historical data from subjects who received a single dose of PXVX0200 in study PXVX-VC-200-004. The data was included in study PXVX-VC-200-005 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Biological: PXVX0200
Seroconversion Rate at Day 11
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Time frame: Day 11
Geometric Mean Titer (GMT)
The Day 11 vibriocidal GMTs were compared between older and younger adults.
Time frame: Day 11
Cumulative Seroconversion Through Day 29 Compared to Day 11 for Younger Adults
The cumulative seroconversion through Day 29 for older adults was compared to the Day 11 seroconversion for the younger adults aged 18 - 45 yrs. Seroconversion is defined as a 4-fold rise in antibody titer relative to baseline values.
Time frame: Day 29
Mean Fold Change in Vibriocidal Antibody Titer Between Day 1 and Day 11
The mean log2 fold change between Day 1 and Day 11 in classical Inaba vibriocidal antibody titer attained by older adults was compared to the younger adults aged 18 - 45 yrs.
Time frame: Day 11
Seroconversion Against Other V. Cholerae Biotypes/Serotypes
Seroconversion of the vibriocidal antibody response against 4 V. cholerae biotypes/serotypes - classical Inaba, El Tor Inaba, classical Ogawa and El Tor Ogawa was assessed.
Time frame: Day 11
Anti-CT Antibody Response in Older Adults
The seroconversion of anti-Cholera Toxin (CT) antibody response in older adults was assessed. Seroconversion is defined as a 4-fold rise in anti-CT antibody titer relative to baseline values.
Time frame: Day 11
This study included healthy volunteers (46 - 64 years) who were not previously immunized against cholera. A total of 398 subjects randomized, of which 299 received study treatment and 99 received placebo. A total of 36 subjects from the treatment group continued in the Immune Sub-study population.
| Milestone | PXVX0200 in Older Adults | Placebo in Older Adults | Historical Control: Adults Aged 18-45 |
|---|---|---|---|
| Started | 299 | 99 | 2688 |
| Completed | 292 | 95 | 2688 |
| Not completed | 7 | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 4 | 0 |
| Withdrew: 3 subjects randomized to treatment unable to receive vaccine as product not available, | 3 | 0 | 0 |
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
| % of participants | PXVX0200 in Older Adults | Historical Control: Adults Aged 18-45 |
|---|---|---|
| Seroconversion Rate at Day 11 | 90.4 (86.4 to 93.5) | 93.5 (92.5 to 94.4) |
The Day 11 vibriocidal GMTs were compared between older and younger adults.
| Geometric Mean Titer | PXVX0200 in Older Adults | Historical Control: Adults Aged 18-45 | Placebo in Older Adults |
|---|---|---|---|
| Geometric Mean Titer (GMT) | 4282 (3344 to 5484) | 9688 (9067 to 10351) | 44 (36 to 56) |
The cumulative seroconversion through Day 29 for older adults was compared to the Day 11 seroconversion for the younger adults aged 18 - 45 yrs. Seroconversion is defined as a 4-fold rise in antibody titer relative to baseline values.
| % of participants | PXVX0200 in Older Adults | Historical Control: Adults Aged 18-45 | Placebo in Older Adults |
|---|---|---|---|
| Cumulative Seroconversion Through Day 29 Compared to Day 11 for Younger Adults | 94.2 (90.8 to 96.6) | 93.5 (92.5 to 94.4) | 1.0 (0.0 to 5.5) |
The mean log2 fold change between Day 1 and Day 11 in classical Inaba vibriocidal antibody titer attained by older adults was compared to the younger adults aged 18 - 45 yrs.
| Fold Change in Titer from Day 1 | PXVX0200 in Older Adults | Historical Control: Adults Aged 18-45 |
|---|---|---|
| Mean Fold Change in Vibriocidal Antibody Titer Between Day 1 and Day 11 | 6.6 (6.2 to 7.0) | 7.1 (7.0 to 7.3) |
Seroconversion of the vibriocidal antibody response against 4 V. cholerae biotypes/serotypes - classical Inaba, El Tor Inaba, classical Ogawa and El Tor Ogawa was assessed.
| % of participants | PXVX0200 in Older Adults | Placebo in Older Adults |
|---|---|---|
| Classical Inaba | 90.4 (86.4 to 93.5) | 0 (0.0 to 3.7) |
| El Tor Inaba | 91.0 (87.1 to 94.1) | 5.1 (1.7 to 11.4) |
| Classical Ogawa | 73.2 (67.7 to 78.2) | 2.0 (0.2 to 7.1) |
| El Tor Ogawa | 71.4 (65.8 to 76.5) | 6.1 (2.3 to 12.7) |
The seroconversion of anti-Cholera Toxin (CT) antibody response in older adults was assessed. Seroconversion is defined as a 4-fold rise in anti-CT antibody titer relative to baseline values.
| % of participants | PXVX0200 in Older Adults | Placebo in Older Adults |
|---|---|---|
| Anti-CT Antibody Response in Older Adults | 55.6 (38.1 to 72.1) | 0 (0.0 to 33.6) |
Collected over Adverse event monitoring for this study will begin post-vaccination on Day 1 and will continue through Day 29 for all adverse events and the End-of-Study visit (Day 181) for serious adverse events. In order to fulfill safety reporting obligations, the Investigator should promptly report any SAEs resulting from study participation through the Day 181 visit.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PXVX0200 in Older Adults | 0/296 (0%) | 3/296 (1%) | 37/296 (12.5%) |
| Placebo in Older Adults | 0/99 (0%) | 0/99 (0%) | 11/99 (11.1%) |
| Event | PXVX0200 in Older Adults | Placebo in Older Adults |
|---|---|---|
| Atrial FibrillationCardiac disorders | 1/296 | 0/99 |
| Spinal Compression FractureInjury, poisoning and procedural complications | 1/296 | 0/99 |
| Myocardial InfarctionCardiac disorders | 1/296 | 0/99 |
| Event | PXVX0200 in Older Adults | Placebo in Older Adults |
|---|---|---|
| FatigueGeneral disorders | 11/296 | 3/99 |
| Back PainNervous system disorders | 6/296 | 2/99 |
| FlatulenceGastrointestinal disorders | 3/296 | 2/99 |
| RashSkin and subcutaneous tissue disorders | 3/296 | 2/99 |
| Decreased AppetiteGastrointestinal disorders | 5/296 | 0/99 |
| HeadacheNervous system disorders | 3/296 | 1/99 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/296 | 1/99 |
| NauseaGastrointestinal disorders | 3/296 | 0/99 |
| Age, Categorical(Participants) | PXVX0200 in Older Adults | Placebo in Older Adults | Historical Control: Adults Aged 18-45 | Total |
|---|---|---|---|---|
| Between 46-64 years (inclusive) — <=18 years | 0 | 0 | 0 | 0 |
| Between 46-64 years (inclusive) — Between 18 and 65 years | 299 | 99 | 2688 | 3086 |
| Between 46-64 years (inclusive) — >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | PXVX0200 in Older Adults | Placebo in Older Adults | Historical Control: Adults Aged 18-45 | Total |
|---|---|---|---|---|
| Mean | 53.8 ± 4.99 | 54.1 ± 5.20 | 30.0 ± 7.8 | 33.1 ± NA |
| Sex: Female, Male(Participants) | PXVX0200 in Older Adults | Placebo in Older Adults | Historical Control: Adults Aged 18-45 | Total |
|---|---|---|---|---|
| Female | 164 | 52 | 1482 | 1698 |
| Male | 135 | 47 | 1206 | 1388 |
| Race (NIH/OMB)(Participants) | PXVX0200 in Older Adults | Placebo in Older Adults | Historical Control: Adults Aged 18-45 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 6 | 1 | 11 | 18 |
| Asian | 0 | 2 | 56 | 58 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 8 | 9 |
| Black or African American | 68 | 19 | 671 | 758 |
| White | 221 | 77 | 1855 | 2153 |
| More than one race | 2 | 0 | 50 | 52 |
| Unknown or Not Reported | 1 | 0 | 37 | 38 |
| Region of Enrollment(participants) | PXVX0200 in Older Adults | Placebo in Older Adults | Historical Control: Adults Aged 18-45 | Total |
|---|---|---|---|---|
| United States | 299 | 99 | 2341 | 2739 |
| Australia | 0 | 0 | 347 | 347 |
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