CompletedNCT02927145Updated Feb 18, 2022Results posted

A Challenge Study to Assess the Safety, Immunogenicity and Efficacy of a Malaria Vaccine Candidate

A Phase 1/2 interventional study of RH5.1/ ASO1 in Malaria, sponsored by University of Oxford. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.

Sponsored by University of Oxford · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 88
Allocation: Non-randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

This is an open-label, multi-centre Phase I/IIa dose escalation blood-stage malaria CHMI trial to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine RH5.1/AS01. All volunteers recruited will be healthy, malaria naïve adults aged between 18 and 45 years.

Volunteers will be recruited and vaccinated at the CCVTM, Oxford; Guys and St Thomas' NIHR CRF, London; and the NIHR WTCRF, Southampton for the Phase Ia part of the trial, and at the CCVTM, Oxford and Guys and St Thomas' NIHR CRF, London for the Phase IIa stage.

Read the detailed description

This is a descriptive phase I trial to assess the safety and immunogenicity of the RH5.1/AS01 vaccine in healthy volunteers at different doses, and to establish whether the RH5.1/AS01 vaccine can demonstrate a reduced parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model.

There will be 6 study groups across two phases of the trial, with a total of 66 - 78 volunteers.

Vaccination of groups will be sequential from Group 1 to Group 3. Group 3 and 4 can be recruited simultaneously. Volunteers will be able to choose which group they are allocated to.

The vaccination dose for Group 5 has been decided following the analysis of safety and exploratory immunology assays from Groups 1, 2 and 4. They will undergo blood-stage CHMI 2 weeks after the final vaccination and will be followed up until approximately 6 months after the final vaccination.

Group 6 volunteers will be infectivity controls, so will not receive any vaccinations.

Volunteers will be recruited and undergo screening visits, vaccination and clinic visits post-vaccination at their local trial site. Procedures will be performed on the visit time points indicated in the schedule of attendances.. Additional procedures or laboratory tests may be performed, at the discretion of the Investigators.

Conditions studied

Malaria

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Malaria 1,315

In context

Malaria

1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 88 is below the median of 220 across 1,041 interventional studies indexed under Malaria.

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Lead sponsor

University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

Inclusion criteria

Healthy adults aged 18 to 45 years.
Able and willing (in the Investigator's opinion) to comply with all study requirements.
Willing to allow the Investigators to discuss the volunteer's medical history with their General Practitioner (GP).
For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination, and on the day prior to blood-stage CHMI, and prior to the start of antimalarial treatment for Group 5 and 6 volunteers.
Agreement to refrain from blood donation during the course of the study.
Provide written informed consent.

Additional Inclusion Criteria for Groups 5 - 6

Agreement to permanently refrain from blood donation, as per current UK Blood Transfusion and Tissue Transplantation Services guidelines.
Reachable (24 hours a day) by mobile phone during the period between CHMI and completion of antimalarial treatment.
Willingness to take a curative anti-malaria regimen following CHMI.
Answer all questions on the informed consent questionnaire correctly.

Exclusion criteria

Exclusion Criteria:

Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Chronic use of antibiotics with antimalarial effects (e.g. tetracyclines for dermatologic patients, sulfa for recurrent urinary tract infections, etc.).
History of malaria chemoprophylaxis within 60 days prior to vaccination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Any history of anaphylaxis in relation to vaccination.
Pregnancy, lactation or willingness/intention to become pregnant during the study.
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
History of serious psychiatric condition likely to affect participation in the study.
Any other serious chronic illness requiring hospital specialist supervision.
Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.
Suspected or known injecting drug abuse in the 5 years preceding enrolment.
Seropositive for hepatitis B surface antigen (HBsAg).
Seropositive for hepatitis C virus (antibodies to HCV).
History of clinical malaria (any species).
Travel to a malaria endemic region during the study period or within the previous six months.
Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis.
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate.

Additional exclusion criteria for groups 5 - 6

Use of systemic antibiotics with known antimalarial activity within 30 days of CHMI (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones and azithromycin).
History of sickle cell anaemia, sickle cell trait, thalassaemia or thalassaemia trait or any haematological condition that could affect susceptibility to malaria infection.
Use of medications known to cause prolongation of the QT interval AND existing contraindication to the use of Malarone.
Use of medications known to have a potentially clinically significant interaction with Riamet AND Malarone.
Contraindications to the use of all three proposed anti-malarial medications; Riamet, Malarone and Chloroquine.
Any clinical condition known to prolong the QT interval.
Family history of congenital QT prolongation or sudden death.
Positive family history in 1st and 2nd degree relatives \< 50 years old for cardiac disease.
History of cardiac arrhythmia, including clinically relevant bradycardia.
Volunteer unable to be closely followed for social, geographic or psychological reasons.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 88 participants (actual)

Study arms

Active comparator
Group 1-Phase Ia
The study is designed to assess a 'standard' protein-in-adjuvant vaccination regimen- 2µg RH5.1/ 0.5mL AS01- of 3 doses given four weeks apart, with dose escalation to assess the best dose in healthy adults.
Biological: RH5.1/ ASO1
Active comparator
Group 2- Phase Ia
The dose used will be- 10µg RH5.1/ 0.5mL AS01. The total number of volunteers recruited to Groups 1 and 2 will be decided based on the immunogenicity of the vaccines at the 2 µg and 10 µg doses. If the doses are immunogenic the groups (1 and 2) will be recruited to a total of 12 volunteers.
Biological: RH5.1/ ASO1
Active comparator
Group 3-Phase Ia
Group 3 will receive 50µg RH5.1/ 0.5mL AS0 The ultimate aim is to assess the safety and immunogenicity of giving the 'standard' first two doses of the vaccine followed by a delayed fractional dose (10 µg).
Biological: RH5.1/ ASO1
Active comparator
Group 4-Phase Ia
Group 3 and 4 will be recruited simultaneously. The dose of vaccine for this group is same as that of 3 (50µg RH5.1/ 0.5mL AS01)
Biological: RH5.1/ ASO1
Active comparator
Group 5-Phase IIa
The vaccination dose for Group 5 was decided following the analysis of safety and exploratory immunology assays from Groups 1, 2 and 4. The dose of vaccine for this group is the same as that of group 2 (10µg RH5.1/ 0.5mL AS01).
Biological: RH5.1/ ASO1
No intervention
Group 6-Phase IIa
Group 6 volunteers will be infectivity controls, so will not receive any vaccinations. Groups 5 and 6 will only be recruited once at least 6 volunteers in Group 4 have completed all vaccinations.
Active comparator
Group 7-Phase IIa
Group 7 are Group 5 volunteers who will receive a fourth dose of IMP (10µg RH5.1/ 0.5mL AS01)
Biological: RH5.1/ ASO1
No intervention
Group 8 -Phase IIa
Group 8 are infectivity controls who were originally in Group 6.
No intervention
Group 9 -Phase IIa
Group 9 are new infectivity controls

Interventions

BiologicalRH5.1/ ASO1
The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum. The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity.

What researchers measure

Primary outcomes

Efficacy of the RH5.1/AS01 Vaccine by Demonstrating a Reduced PMR in Vaccinated Subjects Compared to Infectivity Controls Against 3D7 Clone Parasites in a CHMI Model.
PCR-derived parasite multiplication rate (PMR) will be the primary efficacy endpoint for the Phase IIa stage of the trial, and comparison of the endpoint between the Groups 5 and 6 will constitute the primary analysis for efficacy.
Time frame: Measured during CHMI
Safety of RH5.1/AS01 in Healthy Malaria-naïve Adults in the UK.
Solicited and unsolicited adverse events collected passively and actively for 28 days post each vaccination. Number of volunteers reporting any unsolicited AEs post-any vaccination, as reported to investigators or in electronic diaries.
Time frame: 8 months
the in Vitro Growth Inhibition Activity (GIA) Against 3D7 Clone P. Falciparum Parasites of IgG Purified From the Serum of Vaccinees.
The specific endpoints for GIA in vitro will be assessed from a titration of the purified IgG in the assay.
Time frame: 2 weeks post final vaccination

Secondary outcomes

the Humoral Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.
Antibody responses to the RH5.1 protein generated by vaccination
Time frame: 2 weeks post final vaccination
the Cellular Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.
T cell responses to the RH5.1 protein generated by vaccination
Time frame: 2 weeks post final vaccination
Immunological Readouts for Association With a Reduced Parasite Multiplication Rate.
Statistical correlation between anti-RH5 antibody responses induced by the RH5.1 vaccine and PMR. A non-linear regression curve for all samples combined is available in the trial manuscript ; data is not presented here.
Time frame: 8 months

Results

Posted Feb 18, 2022

Participant flow

Initial Recruitment

Participant flow — Initial Recruitment
Milestone	Group 1-Phase Ia	Group 2- Phase Ia	Group 3-Phase Ia	Group 4-Phase Ia	Group 5-Phase IIa	Group 6-Phase IIa	Group 9 -Phase IIa
Started	12	12	12	14	17	15	6
Completed	12	11	11	10	14	14	4
Not completed	0	1	1	4	3	1	2
Withdrew: Withdrawal by subject	0	1	1	4	1	1	2
Withdrew: Adverse event	0	0	0	0	2	0	0

Invitation for Additional Challenge

Participant flow — Invitation for Additional Challenge
Milestone	Group 7-Phase IIa	Group 8 -Phase IIa
Started	9	8
Completed	8	8
Not completed	1	0
Withdrew: Pregnancy	1	0

Outcome measures

PrimaryEfficacy of the RH5.1/AS01 Vaccine by Demonstrating a Reduced PMR in Vaccinated Subjects Compared to Infectivity Controls Against 3D7 Clone Parasites in a CHMI Model.

PCR-derived parasite multiplication rate (PMR) will be the primary efficacy endpoint for the Phase IIa stage of the trial, and comparison of the endpoint between the Groups 5 and 6 will constitute the primary analysis for efficacy.

Time frame:: Measured during CHMI
Reported as:: Mean · Parisite multiplication rate (PMR)

Efficacy of the RH5.1/AS01 Vaccine by Demonstrating a Reduced PMR in Vaccinated Subjects Compared to Infectivity Controls Against 3D7 Clone Parasites in a CHMI Model.
Parisite multiplication rate (PMR)	Group 1-Phase Ia	Group 2- Phase Ia	Group 3-Phase Ia	Group 4-Phase Ia	Group 5-Phase IIa	Group 6-Phase IIa	Group 7-Phase IIa	Group 8 -Phase IIa	Group 9 -Phase IIa
Efficacy of the RH5.1/AS01 Vaccine by Demonstrating a Reduced PMR in Vaccinated Subjects Compared to Infectivity Controls Against 3D7 Clone Parasites in a CHMI Model.	—	—	—	—	8.12 ± 1.13	9.75 ± 2.46	7.62 ± 1.44	—	11.22 ± 1.92

PrimarySafety of RH5.1/AS01 in Healthy Malaria-naïve Adults in the UK.

Solicited and unsolicited adverse events collected passively and actively for 28 days post each vaccination. Number of volunteers reporting any unsolicited AEs post-any vaccination, as reported to investigators or in electronic diaries.

Time frame:: 8 months
Reported as:: Count of participants · Participants

Safety of RH5.1/AS01 in Healthy Malaria-naïve Adults in the UK.
Participants	Group 1-Phase Ia	Group 2- Phase Ia	Group 3-Phase Ia	Group 4-Phase Ia	Group 5-Phase IIa	Group 7-Phase IIa
Safety of RH5.1/AS01 in Healthy Malaria-naïve Adults in the UK.	9	11	9	10	14	3

Primarythe in Vitro Growth Inhibition Activity (GIA) Against 3D7 Clone P. Falciparum Parasites of IgG Purified From the Serum of Vaccinees.

The specific endpoints for GIA in vitro will be assessed from a titration of the purified IgG in the assay.

Time frame:: 2 weeks post final vaccination
Reported as:: Median · percentage of growth inhibition

the in Vitro Growth Inhibition Activity (GIA) Against 3D7 Clone P. Falciparum Parasites of IgG Purified From the Serum of Vaccinees.
percentage of growth inhibition	Group 1-Phase Ia	Group 2- Phase Ia	Group 3-Phase Ia	Group 4-Phase Ia	Group 5-Phase IIa	Group 6-Phase IIa	Group 7-Phase IIa	Group 8 -Phase IIa	Group 9 -Phase IIa
the in Vitro Growth Inhibition Activity (GIA) Against 3D7 Clone P. Falciparum Parasites of IgG Purified From the Serum of Vaccinees.	75.2 ± 20.25	69.9 ± 11.65	71.3 ± 13.76	71.6 ± 13.18	—	—	—	—	—

Secondarythe Humoral Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.

Antibody responses to the RH5.1 protein generated by vaccination

Time frame:: 2 weeks post final vaccination
Reported as:: Median · ug/mL

the Humoral Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.
ug/mL	Group 1-Phase Ia	Group 2- Phase Ia	Group 3-Phase Ia	Group 4-Phase Ia	Group 5-Phase IIa	Group 6-Phase IIa	Group 7-Phase IIa	Group 8 -Phase IIa	Group 9 -Phase IIa
the Humoral Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.	86.9 ± 51.75	88.1 ± 40.11	124.4 ± 81.62	95.6 ± 56.07	—	—	—	—	—

Secondarythe Cellular Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.

T cell responses to the RH5.1 protein generated by vaccination

Time frame:: 2 weeks post final vaccination
Reported as:: Median · SFU per million PBMC

the Cellular Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.
SFU per million PBMC	Group 1-Phase Ia	Group 2- Phase Ia	Group 3-Phase Ia	Group 4-Phase Ia	Group 5-Phase IIa	Group 6-Phase IIa	Group 7-Phase IIa	Group 8 -Phase IIa	Group 9 -Phase IIa
the Cellular Immunogenicity of RH5.1/AS01 Using Different Vaccine Doses and Vaccination Regimens.	570 ± 439.4	140.7 ± 343.9	277.3 ± 328.4	713.3 ± 396.4	—	—	—	—	—

SecondaryImmunological Readouts for Association With a Reduced Parasite Multiplication Rate.

Statistical correlation between anti-RH5 antibody responses induced by the RH5.1 vaccine and PMR. A non-linear regression curve for all samples combined is available in the trial manuscript ; data is not presented here.

Time frame:: 8 months

Results for this outcome have not been posted.

Adverse events

Collected over Data on solicted adverse events were collected for 7 days after vaccinated and unsolicited adverse events for 28 days post-vaccination. Data on serious adverse events and adverse events of special interest were collected for the study duration. Study duration was 240 days post first vaccination in groups 1, 2 and 4, 366 days post first vaccination in group 3 and 90 days post challenge in groups 5 and 7. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1	0/12 (0%)	0/12 (0%)	9/12 (75%)
Group 2	0/12 (0%)	0/12 (0%)	11/12 (91.7%)
Group 3	0/12 (0%)	1/12 (8.3%)	9/12 (75%)
Group 4	0/14 (0%)	0/14 (0%)	10/14 (71.4%)
Group 5	0/17 (0%)	1/17 (5.9%)	14/17 (82.4%)
Group 6	0/15 (0%)	0/15 (0%)	0/15 (0%)
Group 7	0/9 (0%)	1/9 (11.1%)	3/9 (33.3%)
Group 8	0/8 (0%)	0/8 (0%)	0/8 (0%)
Group 9	0/6 (0%)	0/6 (0%)	0/6 (0%)

Most frequent serious events

Most frequent serious events
Event	Group 1	Group 2	Group 3	Group 4	Group 5	Group 6	Group 7	Group 8	Group 9
PregnancyPregnancy, puerperium and perinatal conditions	0/12	0/12	0/12	0/14	0/17	0/15	1/9	0/8	0/6
PsoriasisSkin and subcutaneous tissue disorders	0/12	0/12	1/12	0/14	0/17	0/15	0/9	0/8	0/6
TonsilectomySurgical and medical procedures	0/12	0/12	0/12	0/14	1/17	0/15	0/9	0/8	0/6

Most frequent other events

Most frequent other events
Event	Group 1	Group 2	Group 3	Group 4	Group 5	Group 6	Group 7	Group 8	Group 9
CoughRespiratory, thoracic and mediastinal disorders	0/12	6/12	1/12	2/14	3/17	0/15	0/9	0/8	0/6
Back PainMusculoskeletal and connective tissue disorders	3/12	1/12	1/12	0/14	0/17	0/15	1/9	0/8	0/6
HeadacheGeneral disorders	2/12	3/12	2/12	2/14	3/17	0/15	0/9	0/8	0/6
Oropharyngeal painGeneral disorders	0/12	3/12	0/12	2/14	4/17	0/15	1/9	0/8	0/6
RhinitisGeneral disorders	0/12	2/12	3/12	2/14	4/17	0/15	0/9	0/8	0/6
RhinorrhoeaGeneral disorders	0/12	3/12	0/12	0/14	1/17	0/15	0/9	0/8	0/6
Local ReactionGeneral disorders	2/12	1/12	2/12	3/14	1/17	0/15	0/9	0/8	0/6
NauseaGastrointestinal disorders	0/12	2/12	2/12	0/14	1/17	0/15	0/9	0/8	0/6
InsomniaGeneral disorders	2/12	0/12	1/12	1/14	0/17	0/15	0/9	0/8	0/6
AthralgiaMusculoskeletal and connective tissue disorders	0/12	0/12	0/12	0/14	0/17	0/15	1/9	0/8	0/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Group 1	Group 2	Group 3	Group 4	Group 5	Group 6	Group 9	Total
<=18 years	0	0	0	0	0	0	0	0
Between 18 and 65 years	12	12	12	14	17	15	6	88
>=65 years	0	0	0	0	0	0	0	0

Age, Continuous
Age, Continuous(Years)	Group 1	Group 2	Group 3	Group 4	Group 5	Group 6	Group 9	Total
Mean	32 (22 to 42)	28 (18 to 45)	29 (25 to 41)	31 (18 to 45)	27 (21 to 39)	27 (20 to 33)	24 (21 to 28)	29 (18 to 45)

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1	Group 2	Group 3	Group 4	Group 5	Group 6	Group 9	Total
Female	9	7	8	9	12	6	4	55
Male	3	5	4	5	5	9	2	33

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Group 1	Group 2	Group 3	Group 4	Group 5	Group 6	Group 9	Total
Count of participants	—	—	—	—	—	—	—	0

Study locations

2 sites

Guys and St Thomas' NIHR CRF
London, United Kingdom
Nihr Wtcrf
Southampton, United Kingdom

References and documents

Publications

Salkeld J, Themistocleous Y, Barrett JR, Mitton CH, Rawlinson TA, Payne RO, Hou MM, Khozoee B, Edwards NJ, Nielsen CM, Sandoval DM, Bach FA, Nahrendorf W, Ramon RL, Baker M, Ramos-Lopez F, Folegatti PM, Quinkert D, Ellis KJ, Poulton ID, Lawrie AM, Cho JS, Nugent FL, Spence PJ, Silk SE, Draper SJ, Minassian AM. Repeat controlled human malaria infection of healthy UK adults with blood-stage Plasmodium falciparum: Safety and parasite growth dynamics. Front Immunol. 2022 Aug 22;13:984323. doi: 10.3389/fimmu.2022.984323. eCollection 2022. PubMed 36072606 ↗
Willcox AC, Huber AS, Diouf A, Barrett JR, Silk SE, Pulido D, King LDW, Alanine DGW, Minassian AM, Diakite M, Draper SJ, Long CA, Miura K. Antibodies from malaria-exposed Malians generally interact additively or synergistically with human vaccine-induced RH5 antibodies. Cell Rep Med. 2021 Jun 21;2(7):100326. doi: 10.1016/j.xcrm.2021.100326. eCollection 2021 Jul 20. PubMed 34337556 ↗
Minassian AM, Silk SE, Barrett JR, Nielsen CM, Miura K, Diouf A, Loos C, Fallon JK, Michell AR, White MT, Edwards NJ, Poulton ID, Mitton CH, Payne RO, Marks M, Maxwell-Scott H, Querol-Rubiera A, Bisnauthsing K, Batra R, Ogrina T, Brendish NJ, Themistocleous Y, Rawlinson TA, Ellis KJ, Quinkert D, Baker M, Lopez Ramon R, Ramos Lopez F, Barfod L, Folegatti PM, Silman D, Datoo M, Taylor IJ, Jin J, Pulido D, Douglas AD, de Jongh WA, Smith R, Berrie E, Noe AR, Diggs CL, Soisson LA, Ashfield R, Faust SN, Goodman AL, Lawrie AM, Nugent FL, Alter G, Long CA, Draper SJ. Reduced blood-stage malaria growth and immune correlates in humans following RH5 vaccination. Med. 2021 Jun 11;2(6):701-719.e19. doi: 10.1016/j.medj.2021.03.014. PubMed 34223402 ↗
Nielsen CM, Ogbe A, Pedroza-Pacheco I, Doeleman SE, Chen Y, Silk SE, Barrett JR, Elias SC, Miura K, Diouf A, Bardelli M, Dabbs RA, Barfod L, Long CA, Haynes BF, Payne RO, Minassian AM, Bradley T, Draper SJ, Borrow P. Protein/AS01B vaccination elicits stronger, more Th2-skewed antigen-specific human T follicular helper cell responses than heterologous viral vectors. Cell Rep Med. 2021 Feb 22;2(3):100207. doi: 10.1016/j.xcrm.2021.100207. eCollection 2021 Mar 16. PubMed 33763653 ↗

Study documents

Protocol and statistical analysis plan · Oct 10, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Jun 2019, 32 months.

Results were first posted in Feb 2022, 2 years 7 months after primary completion.

Of 25 phase 1/2 interventional studies under Malaria, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's 32 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 5, 2016
First posted: Oct 6, 2016
StartActual: Oct 17, 2016
Primary completionActual: Jun 27, 2019
CompletionActual: Jun 27, 2019
Results first posted: Feb 18, 2022
Last update: Feb 18, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02927145
Lead sponsor: University of Oxford
Responsible party: Sponsor
First posted: Oct 6, 2016
Start date: Oct 17, 2016
Primary completion: Jun 27, 2019
Completion: Jun 27, 2019
Results posted: Feb 18, 2022
Last update: Feb 18, 2022

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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