MalariaPhase 1/2NCT01157897
Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults
A Phase 1/2 study testing VMP001 and P. vivax sporozoite challenge in people with Malaria and Plasmodium Vivax, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Plasmodium Vivax
- What is being tested?
- VMP001 and P. vivax sporozoite challenge
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who meet all of the following criteria may participate in this study:
- Healthy adults (male or non-pregnant, non-lactating female) 18 to 55 years of age (inclusive) at the time of enrollment
- If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions until completion of the last study visit.
- Free of significant health problems as established by medical history, laboratory and clinical examination before entering the study
- Duffy positive phenotype (homozygous or heterozygous)
- Normal (non-deficient) Glucose 6-phosphate dehydrogenase (G6PD) phenotype (range: 4.6 to 13.5 units/gm hemoglobin)
Show all 13Show fewer
- Volunteers must have low cardiac risk factors according to the NHANES I criteria and a non-significant electrocardiogram (EKG)
- Available to participate and reachable by phone for duration of study (approximately 9 months)
- No plans to travel to outside the Washington, District of Columbia (DC) area up until treatment course has been completed (post challenge)
- No plans to travel to a malaria endemic area during the course of the study
- Written informed consent must be obtained from the subject before screening procedures
- Volunteers must score at least 80% correct on a 10 or 14 question multiple-choice quiz (control and immunization groups, respectively) that assesses their understanding of this study
- If a subject is active duty military he or she must obtain approval from his or her supervisor per Walter Reed Army Institute of Research (WRAIR) Policy 06-15
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Any history of malaria infection
- History of travel to P. vivax endemic areas in the last three months, and travel to Republic of Korea or China in the last 18 months
- Any history of receiving malaria vaccine or any licensed vaccine within 7 days prior to first immunization
- History of receipt of malaria prophylaxis during the previous 2 months or the use of any drugs with significant anti-malarial activity during the study period one month prior to challenge (for control volunteers). Examples include tetracycline, doxycycline, clindamycin, azithromycin or sulfa drugs
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period.
Show all 27Show fewer
- Any history of allergic reaction or anaphylaxis to previous vaccination
- Allergy to kanamycin, nickel, or imidazole
- Pregnant (positive β-HCG) or nursing at screening or plans to become pregnant or nurse from the time of enrollment until study completion.
- Allergy to antimalarial drugs or use of medications known to cause drug reactions with chloroquine and/or primaquine
- Significant (e.g. systemic) hypersensitivity reactions to mosquito bites (local hypersensitivity reactions at the site of mosquito bites are not an exclusion criterion)
- History of sickle cell disease
- History of psoriasis or porphyria
- History of splenectomy
- Any confirmed or suspected immunodeficiency, including HIV infection
- Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune-modifying drugs within 6 months of immunization. For corticosteroids, this is defined as >20 mg/day prednisone or equivalent. -Inhaled and topical steroids are allowed
- A family history of congenital or hereditary immunodeficiency
- Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history, physical examination, and laboratory evaluation
- History of diabetes or hypertension even if well controlled on medication
- An abnormal baseline screening electrocardiogram (EKG) suggestive of cardiac disease as determined by a clinical investigator
- Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
- Any abnormal baseline laboratory screening tests: Alanine Aminotransferase (ALT) above normal range, -Creatinine above normal range, Hemoglobin out of normal range, Platelet count out of normal range, Total white blood cell count out of normal range
- Hepatomegaly, right upper quadrant abdominal pain or tenderness
- Seropositive for HIV or hepatitis C virus, or HBsAg positive
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or any planned administration during the study period
- Suspected or known current alcohol or drug abuse as determined from the medical history or by physical examination
- Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Center, Walter Reed Army Institute of Reserach
Silver Spring, Maryland, 20910
About this study
Official title: Phase 1/2a Open-label Dose Safety, Reactogenicity, Immunogenicity and Efficacy of the Candidate Plasmodium Vivax Malaria Protein 001 (VMP001) Administered Intramuscularly With GlaxoSmithKline (GSK) Biologicals' Adjuvant System AS01B in Healthy Malaria-Naïve Adults
This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Three doses of VMP001 formulated in AS01B (adjuvant system) will be given intramuscularly at different intervals followed by a challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters will be studied.
Read the detailed description
This is a Phase 1/2a, non-randomized, open label, dose escalation study in healthy, malaria-naïve adults aged 18 to 55 years (inclusive). The vaccine will be administered with GlaxoSmithKline Biologicals' adjuvant system AS01B. This is a first-in-human study of VMP001; therefore the study design will incorporate a dose-escalation phase evaluating 15 µg, 30 µg, and 60 µg doses of VMP001 in 500 µL of AS01B. A total of 30 volunteers, divided into 3 groups (10 in each group), will receive 3 doses of the VMP001/AS01B vaccine. Group 1 will receive 15 µg of VMP001, Group 2 will receive 30 µg of VMP001, and Group 3 will receive 60 µg of VMP001 at each immunization. The dose of AS01B will be 500 µL for all groups. The first and second dose in each group will be separated by 28 days. The third dose in the three groups will be given at intervals scheduled to normalize the time to challenge between the last immunization and challenge. The second and third dose in Group 1 will be separated by 56 days, Group 2 by 42 days and Group 3 by 28 days. The challenge will occur 2 weeks following the third immunization. A group of 6-12 infectivity controls will begin participation in the study at the challenge stage. They will not receive any immunizations or placebos prior to challenge. All volunteers will receive a standard treatment regimen consisting of chloroquine and primaquine on the day that parasitemia is detected. Volunteers who do not become parasitemic will also begin the same treatment regimen on day 28 following the challenge (study day 126).
>
> Safety and immunogenicity will be evaluated during the study through the final study visit 6 months after challenge (study day 280).
- Conditions
- Malaria, Plasmodium Vivax
- Being tested
- VMP001, P. vivax sporozoite challenge
- Keywords
- Malaria, Plasmodium Vivax, Vaccine
- Medical subject headings
- Malaria, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMP001Biological
Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
P. vivax sporozoite challengeOther
- vivax sporozoite challenge
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 15 μg VMP001 | Experimental | 15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98. Receives: Biological: VMP001; Other: P. vivax sporozoite challenge |
| Cohort 2: 30 μg VMP001 | Experimental | 30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98. Receives: Biological: VMP001; Other: P. vivax sporozoite challenge |
| Cohort 3: 60 μg VMP001 | Experimental | 60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98. Receives: Biological: VMP001; Other: P. vivax sporozoite challenge |
| Control | Other | No Vaccinations given for controls. P. vivax sporozoite challenge on day 98. Receives: Other: P. vivax sporozoite challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.
Measured: 7 days after immunization
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Adverse events were evaluated over a 28 day follow-up period after each vaccination during the vaccine phase
Measured: 28 days following immunization
Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)
Occurrence of serious adverse events at any time during the approximately 463 day study period
Measured: up to 463 days
Secondary outcomes (3)
Time to Parasitemia for Immunogenicity Population
Subjects were ranked according to time of onset of parasitemia and a non-parametric rankorder statistical test (eg, Log-Rank or Mann-Whitney) was performed to evaluate delays in parasitemia induced by vaccination. Cox Proportional Hazards model was used to calculate days to parasitemia and Kaplan-Meier plots were used to display time to first positive malaria blood smear.
Hazard Ratio (HR). Time starts once subject has received t infectious bites. Time stops when subject has first positive blood smear. If subject does not become parasitemic then time stops the day he/she begins anti-malarial therapy.
Measured: 280 day (during the study through 6 months aftr challenge)
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '>50' were converted to '1'.
Measured: study duration
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '>50' were converted to '1'.
Measured: study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR), United States Department of Defense, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Jason Bennett, MD, Principal investigator, Division of Malaria Vaccine Development (DMVD), Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157897
- Sponsor's protocol ID
- WRAIR 1692
- Other IDs
- IND 14380
- Status last verified
- May 2019
- First submitted
- 2 Jul 2010
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bennett JW, Pybus BS, Yadava A, Tosh D, Sousa JC, McCarthy WF, Deye G, Melendez V, Ockenhouse CF. Primaquine failure and cytochrome P-450 2D6 in Plasmodium vivax malaria. N Engl J Med. 2013 Oct 3;369(14):1381-2. doi: 10.1056/NEJMc1301936. No abstract available.
PubMed 24088113Kamau E, Bennett JW, Yadava A. Safety and Tolerability of Mosquito Bite-Induced Controlled Human Infection with Plasmodium vivax in Malaria-Naive Study Participants-Clinical Profile and Utility of Molecular Diagnostic Methods. J Infect Dis. 2022 Jan 5;225(1):146-156. doi: 10.1093/infdis/jiab332.
PubMed 34161579
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Open-label Dose Safety, Reactogenicity, Immunogenicity and Efficacy of the Candidate Plasmodium Vivax Malaria Protein 001 (VMP001) Administered Intramuscularly With GlaxoSmithKline (GSK) Biologicals' Adjuvant System AS01B in Healthy Malaria-Naïve Adults
- ClinicalTrials.gov ID
- NCT01157897
- Acronym / sponsor ID
- WRAIR 1692
- Conditions
- Malaria, Plasmodium Vivax
- Keywords
- Malaria, Plasmodium Vivax, Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR), United States Department of Defense, GlaxoSmithKline
- Study start
- Jul 2010 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Three doses of VMP001 formulated in AS01B (adjuvant system) will be given intramuscularly at different intervals followed by a challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters will be studied.
Detailed description
This is a Phase 1/2a, non-randomized, open label, dose escalation study in healthy, malaria-naïve adults aged 18 to 55 years (inclusive). The vaccine will be administered with GlaxoSmithKline Biologicals' adjuvant system AS01B. This is a first-in-human study of VMP001; therefore the study design will incorporate a dose-escalation phase evaluating 15 µg, 30 µg, and 60 µg doses of VMP001 in 500 µL of AS01B. A total of 30 volunteers, divided into 3 groups (10 in each group), will receive 3 doses of the VMP001/AS01B vaccine. Group 1 will receive 15 µg of VMP001, Group 2 will receive 30 µg of VMP001, and Group 3 will receive 60 µg of VMP001 at each immunization. The dose of AS01B will be 500 µL for all groups. The first and second dose in each group will be separated by 28 days. The third dose in the three groups will be given at intervals scheduled to normalize the time to challenge between the last immunization and challenge. The second and third dose in Group 1 will be separated by 56 days, Group 2 by 42 days and Group 3 by 28 days. The challenge will occur 2 weeks following the third immunization. A group of 6-12 infectivity controls will begin participation in the study at the challenge stage. They will not receive any immunizations or placebos prior to challenge. All volunteers will receive a standard treatment regimen consisting of chloroquine and primaquine on the day that parasitemia is detected. Volunteers who do not become parasitemic will also begin the same treatment regimen on day 28 following the challenge (study day 126).
>
> Safety and immunogenicity will be evaluated during the study through the final study visit 6 months after challenge (study day 280).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 15 μg VMP001 | Experimental | Biological: VMP001, Other: P. vivax sporozoite challenge15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98. |
| Cohort 2: 30 μg VMP001 | Experimental | Biological: VMP001, Other: P. vivax sporozoite challenge30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98. |
| Cohort 3: 60 μg VMP001 | Experimental | Biological: VMP001, Other: P. vivax sporozoite challenge60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98. |
| Control | Other | Other: P. vivax sporozoite challengeNo Vaccinations given for controls. P. vivax sporozoite challenge on day 98. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects who meet all of the following criteria may participate in this study:
- Healthy adults (male or non-pregnant, non-lactating female) 18 to 55 years of age (inclusive) at the time of enrollment
- If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions until completion of the last study visit.
- Free of significant health problems as established by medical history, laboratory and clinical examination before entering the study
- Duffy positive phenotype (homozygous or heterozygous)
Key exclusion criteria (27 listed)
- Subjects meeting any of the following criteria will be excluded from the study:
- Any history of malaria infection
- History of travel to P. vivax endemic areas in the last three months, and travel to Republic of Korea or China in the last 18 months
- Any history of receiving malaria vaccine or any licensed vaccine within 7 days prior to first immunization
- History of receipt of malaria prophylaxis during the previous 2 months or the use of any drugs with significant anti-malarial activity during the study period one month prior to challenge (for control volunteers). Examples include tetracycline, doxycycline, clindamycin, azithromycin or sulfa drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VMP001Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B | Biological | Cohort 1: 15 μg VMP001, Cohort 2: 30 μg VMP001, Cohort 3: 60 μg VMP001 |
| P. vivax sporozoite challengeP. vivax sporozoite challenge | Other | Cohort 1: 15 μg VMP001, Cohort 2: 30 μg VMP001, Cohort 3: 60 μg VMP001, Control |
Primary outcome
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
Time frame: 7 days after immunization
Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
Time frame: 28 days following immunization
Adverse events were evaluated over a 28 day follow-up period after each vaccination during the vaccine phase
Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)
Time frame: up to 463 days
Occurrence of serious adverse events at any time during the approximately 463 day study period
3 secondary outcomes
Time to Parasitemia for Immunogenicity Population
Time frame: 280 day (during the study through 6 months aftr challenge)
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
Time frame: study duration
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
Time frame: study duration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24088113Bennett JW, Pybus BS, Yadava A, Tosh D, Sousa JC, McCarthy WF, Deye G, Melendez V, Ockenhouse CF. Primaquine failure and cytochrome P-450 2D6 in Plasmodium vivax malaria. N Engl J Med. 2013 Oct 3;369(14):1381-2. doi: 10.1056/NEJMc1301936. No abstract available.
- Derived from this study: PubMed 34161579Kamau E, Bennett JW, Yadava A. Safety and Tolerability of Mosquito Bite-Induced Controlled Human Infection with Plasmodium vivax in Malaria-Naive Study Participants-Clinical Profile and Utility of Molecular Diagnostic Methods. J Infect Dis. 2022 Jan 5;225(1):146-156. doi: 10.1093/infdis/jiab332.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Bennett, MD principal investigator
Division of Malaria Vaccine Development (DMVD), Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VMP001 and P. vivax sporozoite challenge in people with Malaria and Plasmodium Vivax, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase (time frame: 7 days after immunization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157897, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.