MalariaPhase 1NCT01540474
Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults
A Phase 1 study testing Group 1: 10 ug FMP012 with 2 ug GLA-SE, Group 2: 10 ug FMP012 with 5 ug GLA-SE and 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE in people with Malaria, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Group 1: 10 ug FMP012 with 2 ug GLA-SE, Group 2: 10 ug FMP012 with 5 ug GLA-SE and 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- History of malaria infection
- History of travel to P. falciparum endemic areas in the 3 months prior to day of first vaccination or day of challenge
- History of receiving a malaria vaccine
- Receipt of any licensed vaccine within 7 days prior to first vaccination
- History of receipt of malaria prophylaxis during the 2 months prior to day of first vaccination or day of challenge
- History of use of any drugs with significant antimalarial activity during the course of the study period
Show all 28Show fewer
- Prior receipt of any vaccine containing either QS-21, MPL or GLA-SE in the previous 5 years (including Cervarix®, GSK)
- 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.
- Any history of allergic reaction or anaphylaxis to previous vaccination
- Allergy to kanamycin, nickel, or imidazole Pregnant or lactating female at screening or plans to become pregnant or breastfeed from the time of enrollment until three months after challenge
- Allergy to antimalarial drugs or use of medications known to interact with both CQ and artemether/lumefantrine
- Significant (eg, systemic) hypersensitivity reactions to mosquito bites
- 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 six months of vaccination
- 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, or laboratory evaluation
- Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or any planned administration during the study period
- Any abnormal baseline laboratory screening tests listed below (normal values are defined in the adverse event section of this protocol):
- Seropositive for HIV or Hepatitis C virus or HBsAg positive
- Hepatomegaly, right upper quadrant abdominal pain or tenderness
- An abnormal baseline screening EKG.
- 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 PI 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, WRAIR
Silver Spring, Maryland, 20910
About this study
Official title: Phase 1 Study With the Vaccine Candidate Plasmodium Falciparum Malaria Protein (FMP012), an E.Coli-expressed Cell-Traversal Protein, Administered Intramuscularly in Healthy Malaria-Naive Adults
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets, clothing, and antimalarial treatment. To be effective, these methods must be self-administered and be used consistently, often unattainable in field or combat situations. The United States Army Medical Research and Development Command (USAMRMC), through the United States Army Medical Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum malaria; development of such a vaccine is a high priority for the US military and other individuals who travel to endemic regions, and is equally important to populations residing in those areas.
A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine will
- assess the safety and reactogenicity of candidate P. falciparum malaria vaccine FMP012/GLA-SE Secondary:
- measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent assay (ELISA)
- assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite challenge.
Read the detailed description
Single center, non-randomized, open label, dose escalation Phase 1study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant produced by the Infectious Disease Research Institute (IDRI). This is a first-in-human study of FMP012. Thirty subjects, divided into 3 groups (10 subjects per group), will receive 3 doses of the FMP012/GLA-SE vaccine. Group 1 will receive 10 µg of FMP012 formulated with 2 µg GLA-SE adjuvant and Group 2 will receive 10 µg of FMP012 formulated with 5 µg GLA-SE adjuvant. Group 3 will receive 50 µg of FMP012 formulated with either 5 µg GLA-SE adjuvant (Group 3a) or 2 µg GLA-SE adjuvant (Group 3b). Determination of whether to proceed with Group 3a or Group 3b will be made by the principal investigator (PI) and the independent medical monitor after the second vaccination dose in Group 2 has been completed, based on predefined safety and group hold criteria in this protocol. There will be a staggered start for Group 1 and Group 2 separated by a minimum of 14 days. Group 3a or Group 3b will start vaccinations 2 weeks after the second vaccination for Group 2. The first and second vaccination doses in each group will be separated by 28 days and all groups will receive the third vaccination dose on the same day. The second and third vaccination doses in Group 1 will be separated by 84 days, Group 2 by 70 days, and Group 3 by 28 days. Six non-immunized infectivity control subjects will be enrolled prior to the challenge phase. All subjects from the Vaccination Group and Infectivity Control Group will participate in the primary malaria sporozoite challenge and will be required to stay at a hotel for evaluation for a maximum of 10 nights starting 9 days after the challenge. A directly monitored, sequentially allocated, open-label oral regimen of chloroquine or artemether/lumefantrine will be administered to all parasitemic subjects.
- Conditions
- Malaria
- Being tested
- Group 1: 10 ug FMP012 with 2 ug GLA-SE, Group 2: 10 ug FMP012 with 5 ug GLA-SE, 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE, Controlled group-Challenged Only: no vaccination
- Keywords
- Interference of malaria infection
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: 10 ug FMP012 with 2 ug GLA-SEBiological
Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
Group 2: 10 ug FMP012 with 5 ug GLA-SEBiological
E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SEBiological
E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
Controlled group-Challenged Only: no vaccinationOther
The control group participated in the primary malaria sporozoite challenge.E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 10 ug FMP012 with 2 ug GLA-SE | Experimental | Single center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant Receives: Biological: Group 1: 10 ug FMP012 with 2 ug GLA-SE |
| Group 2: 10 ug FMP012 with 5 ug GLA-SE | Experimental | Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant Receives: Biological: Group 2: 10 ug FMP012 with 5 ug GLA-SE |
| Group 3: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE | Experimental | Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant Receives: Biological: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE |
| Control group-Challenged Only | Other | Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant Receives: Other: Controlled group-Challenged Only: no vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Number of participants for each dose (1 through 3) that experienced any symptom, general solicited symptoms, and local solicited symptoms
Measured: From vaccination day through 7 days post vaccination (for all three doses)
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Incidence of erythema and pain (solicited local symptoms) reported after each dose (1-3) of vaccination. Results for groups 1, 2 and 3 only as control group did not receive any vaccinations and only participated in the malaria challenge portion of the study.
Measured: From vaccination day through 7 days post vaccination for each does (1-3)
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
Number of participants with at lease one administered dose presenting with at least one specified symptom within 28 days after vaccination
Measured: 28 days after each vaccination
Secondary outcomes (2)
Humoral Immune Response to FMP012/GLA-SE
Seroconversion was defined as a post-second vaccination titer (serum dilution of 1:100) that is 3 standard deviations higher than the average of the negative or pre-vaccination serum measured using enzyme-linked immunosorbent assay (ELISA). Values reported as "below the detection limit" were given a value of 50 units. The safety population was used for immunogenicity analysis. Only subjects who received vaccinations or were challenged were included in the analysis of immunogenicity. Subjects who withdrew from the study had data collected to the point of withdraw.
Geometric mean titers (GMT) were obtained by first calculating the mean and 95% confidence intervals for log-transformed values of the ELISA results, followed by exponentiation of the values. Among those vaccinated, all values were below the detection limit until post-dose II.
Measured: Up to 1 year
Time to Onset of Parasitemia Following Sporozoite Challenge
Protective Efficacy of FMP012/GLA-SE Measured against a P falciparum sporozoite challenge. Vaccinated subjects were compared to infectivity controls to assess for delayed onset of parasitemia. Time of onset of parasitemia was based on the date of sporozoite challenge to the date of first positive blood smear detection.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionDec 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- United States Agency for International Development (USAID), Access to Advanced Health Institute (AAHI)
- Responsible party
- Sponsor
- Investigators
- Jessica J. Cowden, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540474
- Sponsor's protocol ID
- S-11-21
- Other IDs
- IND 014962
- Status last verified
- May 2021
- First submitted
- 9 Feb 2012
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study With the Vaccine Candidate Plasmodium Falciparum Malaria Protein (FMP012), an E.Coli-expressed Cell-Traversal Protein, Administered Intramuscularly in Healthy Malaria-Naive Adults
- ClinicalTrials.gov ID
- NCT01540474
- Acronym / sponsor ID
- S-11-21
- Conditions
- Malaria
- Keywords
- Interference of malaria infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- United States Agency for International Development (USAID), Access to Advanced Health Institute (AAHI)
- Study start
- Feb 2012 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10) Currently, the methods used for protecting troops against malaria are insecticidal nets, clothing, and antimalarial treatment. To be effective, these methods must be self-administered and be used consistently, often unattainable in field or combat situations. The United States Army Medical Research and Development Command (USAMRMC), through the United States Army Medical Materiel Development Activity (USAMMDA) and the Walter Reed Army Institute of Research (WRAIR) are actively pursuing the development of an effective vaccine against P. falciparum malaria; development of such a vaccine is a high priority for the US military and other individuals who travel to endemic regions, and is equally important to populations residing in those areas.
A Phase 1 study using FMP012, a recombinant E.coli expressed malaria protein (CelTOS) vaccine will
- assess the safety and reactogenicity of candidate P. falciparum malaria vaccine FMP012/GLA-SE Secondary:
- measure the humoral immune response to FMP012/GLA-SE using enzyme-linked immunosorbent assay (ELISA)
- assess the protective efficacy of FMP012/GLA-SE against a P. falciparum sporozoite challenge.
Detailed description
Single center, non-randomized, open label, dose escalation Phase 1study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant produced by the Infectious Disease Research Institute (IDRI). This is a first-in-human study of FMP012. Thirty subjects, divided into 3 groups (10 subjects per group), will receive 3 doses of the FMP012/GLA-SE vaccine. Group 1 will receive 10 µg of FMP012 formulated with 2 µg GLA-SE adjuvant and Group 2 will receive 10 µg of FMP012 formulated with 5 µg GLA-SE adjuvant. Group 3 will receive 50 µg of FMP012 formulated with either 5 µg GLA-SE adjuvant (Group 3a) or 2 µg GLA-SE adjuvant (Group 3b). Determination of whether to proceed with Group 3a or Group 3b will be made by the principal investigator (PI) and the independent medical monitor after the second vaccination dose in Group 2 has been completed, based on predefined safety and group hold criteria in this protocol. There will be a staggered start for Group 1 and Group 2 separated by a minimum of 14 days. Group 3a or Group 3b will start vaccinations 2 weeks after the second vaccination for Group 2. The first and second vaccination doses in each group will be separated by 28 days and all groups will receive the third vaccination dose on the same day. The second and third vaccination doses in Group 1 will be separated by 84 days, Group 2 by 70 days, and Group 3 by 28 days. Six non-immunized infectivity control subjects will be enrolled prior to the challenge phase. All subjects from the Vaccination Group and Infectivity Control Group will participate in the primary malaria sporozoite challenge and will be required to stay at a hotel for evaluation for a maximum of 10 nights starting 9 days after the challenge. A directly monitored, sequentially allocated, open-label oral regimen of chloroquine or artemether/lumefantrine will be administered to all parasitemic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 10 ug FMP012 with 2 ug GLA-SE | Experimental | Biological: Group 1: 10 ug FMP012 with 2 ug GLA-SESingle center, non-randomized, open label, dose escalation Phase 1 study with sporozoite challenge. The antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion. This is a first-in-human study of FMP012. 30 subjects, divided into 3 groups, will receive 3 doses of the FMP012/GLA-SE vaccine. Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant |
| Group 2: 10 ug FMP012 with 5 ug GLA-SE | Experimental | Biological: Group 2: 10 ug FMP012 with 5 ug GLA-SEBiological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant |
| Group 3: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE | Experimental | Biological: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SEBiological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant |
| Control group-Challenged Only | Other | Other: Controlled group-Challenged Only: no vaccinationBiological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (28 listed)
- History of malaria infection
- History of travel to P. falciparum endemic areas in the 3 months prior to day of first vaccination or day of challenge
- History of receiving a malaria vaccine
- Receipt of any licensed vaccine within 7 days prior to first vaccination
- History of receipt of malaria prophylaxis during the 2 months prior to day of first vaccination or day of challenge
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 |
|---|---|---|
| Group 1: 10 ug FMP012 with 2 ug GLA-SEBiological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant | Biological | Group 1: 10 ug FMP012 with 2 ug GLA-SE |
| Group 2: 10 ug FMP012 with 5 ug GLA-SEE-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant | Biological | Group 2: 10 ug FMP012 with 5 ug GLA-SE |
| 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SEE-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant | Biological | Group 3: 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE |
| Controlled group-Challenged Only: no vaccinationThe control group participated in the primary malaria sporozoite challenge.E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant | Other | Control group-Challenged Only |
Primary outcome
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Time frame: From vaccination day through 7 days post vaccination (for all three doses)
Number of participants for each dose (1 through 3) that experienced any symptom, general solicited symptoms, and local solicited symptoms
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period
Time frame: From vaccination day through 7 days post vaccination for each does (1-3)
Incidence of erythema and pain (solicited local symptoms) reported after each dose (1-3) of vaccination. Results for groups 1, 2 and 3 only as control group did not receive any vaccinations and only participated in the malaria challenge portion of the study.
Subjects Reporting the Occurrence of Unsolicited Adverse Events Related to Vaccination
Time frame: 28 days after each vaccination
Number of participants with at lease one administered dose presenting with at least one specified symptom within 28 days after vaccination
2 secondary outcomes
Humoral Immune Response to FMP012/GLA-SE
Time frame: Up to 1 year
Time to Onset of Parasitemia Following Sporozoite Challenge
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jessica J. Cowden, MD principal investigator
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 study testing Group 1: 10 ug FMP012 with 2 ug GLA-SE, Group 2: 10 ug FMP012 with 5 ug GLA-SE and 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE in people with Malaria, 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 0 inclusion and 28 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 8 Jun 2021. 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 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.
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 8 Jun 2021). 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?
Number of Participants With Solicited or Unsolicited Symptoms Reporting During the Post-vaccination Period (time frame: From vaccination day through 7 days post vaccination (for all three doses)). 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?
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 8 Jun 2021.