Human Papillomavirus InfectionsPhase 1/2NCT03610581
Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix
A Phase 1/2 study testing Ad26.HPV16, Ad26.HPV18 and MVA.HPV16/18 in people with Human Papillomavirus Infections, run by Janssen Vaccines & Prevention B.V. at 12 sites in 2 countries.
Trial summary
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Human Papillomavirus Infections
- What is being tested?
- Ad26.HPV16, Ad26.HPV18 and MVA.HPV16/18
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 27 Sep 2018to 15 Oct 2020
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Must have an human papillomavirus (HPV) type 16 or 18 infection of the cervix as determined by a qualitative PCR test within 8 weeks prior to screening or at the time of screening. Available history of high-risk (HR)-HPV positivity and HPV16 or HPV18 positivity positivity will be recorded
- Must have a recent colposcopy result (with a maximum of 12 months old at screening); in case a colposcopy has not been performed before, it will be done as screening procedure
- Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
- Agrees not to donate blood until 3 months after receiving the last dose of study vaccine
Who cannot join
- In case cytology results are available, participant has current or history of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS) or any high-grade vulvar, vaginal or anal intraepithelial neoplasia
- Current or history of cervical intraepithelial neoplasia (CIN)2+ or cervical cancer
- Confirmed co-infection with both HPV16 and HPV18
- History of an underlying clinically significant acute or chronic medical condition, other than infection with HPV, or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Tests positive for human immunodeficiency virus (HIV) at screening
- Chronic active hepatitis B or hepatitis C infection, verified at screening by hepatitis B surface antigen or anti-hepatitis C virus antibody, respectively
Show all 10Show fewer
- Vaginal atrophy with or without topical hormonal therapies or systemic selective estrogen receptor modulators
- Exposed to at least 1 dose of an HPV prophylactic vaccine or participant has participated in the past in another preventive or therapeutic HPV vaccine study
- Clinically significant gynecological abnormalities that could, in the judgment of the investigator, interfere with study evaluation (for example [e.g.], prolapse, myoma, fibroid, hysterectomy)
- Symptomatic vaginal or genital infection (including genital herpes) as confirmed by physician or investigator
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Doral Medical Research
Doral, Florida, 33166
Clinical Physiology Associates
Fort Myers, Florida, 33912
University of Iowa Hospital
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66160
VGR & NOCCR - Knoxville
Knoxville, Tennessee, 37920
Medpharmics, LLC
Metairie, Louisiana, 70006
Florida Research Center Inc.
Miami, Florida, 33174
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
Columbia University Medical Center
New York, New York, 10032
Heartland Research Associates, LLC
Newton, Kansas, 67114
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With HPV16 or 18 Infection of the Cervix
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
Read the detailed description
This study is part of a vaccine program which aims to generate a therapeutic vaccine for women with HPV types 16 or 18 infection, with a focus on early disease interception. The study consists of 3 periods: Screening period of up to 42 days (6 weeks), followed by prime and boost immunizations and follow-up visits up to 12 months after the first vaccination. Evaluation of the safety/reactogenicity of the vaccine regimens will include physical assessment by study-site personnel, participant reports on signs and symptoms and laboratory assessments following vaccinations. Immunogenicity and Virology/Histology assessments will also be performed.
- Conditions
- Human Papillomavirus Infections
- Being tested
- Ad26.HPV16, Ad26.HPV18, MVA.HPV16/18, Placebo
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.HPV16Biological
Also called JNJ-63682918
Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
Ad26.HPV18Biological
Also called JNJ-63682931
Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
MVA.HPV16/18Biological
Also called JNJ-65195208
Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
PlaceboBiological
Participants will receive matched placebo as a solution for intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18 | Experimental | Participants will receive a dose of adenovirus serotype 26 (Ad26)-human papillomavirus (HPV)16 or HPV18 (Ad26.HPV16 or Ad26.HPV18) as prime immunization and a dose of Modified Vaccinia Ankara (MVA)-HPV16/18 (MVA.HPV16/18) as boost immunization. Receives: Biological: Ad26.HPV16; Biological: Ad26.HPV18; Biological: MVA.HPV16/18 |
| Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18 | Experimental | Participants will receive a double dose of Ad26.HPV16 or Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization. Receives: Biological: Ad26.HPV16; Biological: Ad26.HPV18; Biological: MVA.HPV16/18 |
| Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18 | Experimental | Participants will receive a mix of Ad26.HPV16/Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization. Receives: Biological: Ad26.HPV16; Biological: Ad26.HPV18; Biological: MVA.HPV16/18 |
| Control: Placebo | Placebo comparator | Participants will receive matched placebo as prime and boost immunizations. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local Adverse Events (AEs)
Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.
Measured: Up to 7 days after each vaccination (Up to Day 64)
Number of Participants With Solicited Systemic AEs
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.
Measured: Up to 7 days after each vaccination (Up to Day 64)
Number of Participants With Unsolicited AEs
Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary.
Measured: 28 days after each vaccination (Up to Day 85)
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Up to 12 months after the first vaccination (target visit Day 366)
Secondary outcomes (6)
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+
Percentage of participants with HPV-Specific CD4+ T-cell responses for IFNg+ to peptide pools were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Measured: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+
Percentage of participants with HPV-Specific CD4+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Measured: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+
Percentage of participants with HPV-Specific CD4+ T-cell responses for TNF a+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Measured: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+
Percentage of participants with HPV-Specific CD8+ T-cell responses for IFNg+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Measured: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+
Percentage of participants with HPV-Specific CD8+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Measured: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+
Percentage of participants with HPV-Specific CD8+ T-cell responses for TNFa+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both).
Measured: Day 57, Day 78, Day 239, and Day 366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start27 Sep 2018
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Why it stopped: Low enrolment and increasing COVID restrictions, following an earlier enrolment pause in April made it clear that completion of the study would not be feasible
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 Human Papillomavirus InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bavarian Nordic
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610581
- Sponsor's protocol ID
- CR108458
- Other IDs
- 2018-000200-41, VAC81623HPV1002, 2018
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2018
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With HPV16 or 18 Infection of the Cervix
- ClinicalTrials.gov ID
- NCT03610581
- Acronym / sponsor ID
- CR108458
- Conditions
- Human Papillomavirus Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrolment and increasing COVID restrictions, following an earlier enrolment pause in April made it clear that completion of the study would not be feasible
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Collaborators
- Bavarian Nordic
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
Detailed description
This study is part of a vaccine program which aims to generate a therapeutic vaccine for women with HPV types 16 or 18 infection, with a focus on early disease interception. The study consists of 3 periods: Screening period of up to 42 days (6 weeks), followed by prime and boost immunizations and follow-up visits up to 12 months after the first vaccination. Evaluation of the safety/reactogenicity of the vaccine regimens will include physical assessment by study-site personnel, participant reports on signs and symptoms and laboratory assessments following vaccinations. Immunogenicity and Virology/Histology assessments will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18 | Experimental | Biological: Ad26.HPV16, Biological: Ad26.HPV18, Biological: MVA.HPV16/18Participants will receive a dose of adenovirus serotype 26 (Ad26)-human papillomavirus (HPV)16 or HPV18 (Ad26.HPV16 or Ad26.HPV18) as prime immunization and a dose of Modified Vaccinia Ankara (MVA)-HPV16/18 (MVA.HPV16/18) as boost immunization. |
| Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18 | Experimental | Biological: Ad26.HPV16, Biological: Ad26.HPV18, Biological: MVA.HPV16/18Participants will receive a double dose of Ad26.HPV16 or Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization. |
| Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18 | Experimental | Biological: Ad26.HPV16, Biological: Ad26.HPV18, Biological: MVA.HPV16/18Participants will receive a mix of Ad26.HPV16/Ad26.HPV18 as prime immunization and a dose of MVA.HPV16/18 as boost immunization. |
| Control: Placebo | Placebo comparator | Biological: PlaceboParticipants will receive matched placebo as prime and boost immunizations. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Must have an human papillomavirus (HPV) type 16 or 18 infection of the cervix as determined by a qualitative PCR test within 8 weeks prior to screening or at the time of screening. Available history of high-risk (HR)-HPV positivity and HPV16 or HPV18 positivity positivity will be recorded
- Must have a recent colposcopy result (with a maximum of 12 months old at screening); in case a colposcopy has not been performed before, it will be done as screening procedure
- Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
- Agrees not to donate blood until 3 months after receiving the last dose of study vaccine
Key exclusion criteria (10 listed)
- In case cytology results are available, participant has current or history of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS) or any high-grade vulvar, vaginal or anal intraepithelial neoplasia
- Current or history of cervical intraepithelial neoplasia (CIN)2+ or cervical cancer
- Confirmed co-infection with both HPV16 and HPV18
- History of an underlying clinically significant acute or chronic medical condition, other than infection with HPV, or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Tests positive for human immunodeficiency virus (HIV) at screening
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 |
|---|---|---|
| Ad26.HPV16Also: JNJ-63682918Participants will receive Ad26.HPV16 as a solution for intramuscular injection. | Biological | Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18, Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18, Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18 |
| Ad26.HPV18Also: JNJ-63682931Participants will receive Ad26.HPV18 as a solution for intramuscular injection. | Biological | Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18, Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18, Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18 |
| MVA.HPV16/18Also: JNJ-65195208Participants will receive MVA.HPV16/18 as a solution for intramuscular injection. | Biological | Regimen 1: Single Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18, Regimen 2: Double Ad26.HPV16 or Ad26.HPV18 and MVA.HPV16/18, Regimen 3: Ad26.HPV16/Ad26.HPV18 mix and MVA.HPV16/18 |
| PlaceboParticipants will receive matched placebo as a solution for intramuscular injection. | Biological | Control: Placebo |
Primary outcome
Number of Participants With Solicited Local Adverse Events (AEs)
Time frame: Up to 7 days after each vaccination (Up to Day 64)
Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.
Number of Participants With Solicited Systemic AEs
Time frame: Up to 7 days after each vaccination (Up to Day 64)
Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.
Number of Participants With Unsolicited AEs
Time frame: 28 days after each vaccination (Up to Day 85)
Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 12 months after the first vaccination (target visit Day 366)
Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
6 secondary outcomes
Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+
Time frame: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+
Time frame: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+
Time frame: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+
Time frame: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+
Time frame: Day 57, Day 78, Day 239, and Day 366
Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+
Time frame: Day 57, Day 78, Day 239, and Day 366
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- 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.
Janssen Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad26.HPV16, Ad26.HPV18 and MVA.HPV16/18 in people with Human Papillomavirus Infections, run by Janssen Vaccines & Prevention B.V. at 12 sites in 2 countries.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Belgium. 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. Some participants in this study may receive a placebo. 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 9 Nov 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 Local Adverse Events (AEs) (time frame: Up to 7 days after each vaccination (Up to Day 64)). The study lists 4 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 4 Feb 2025.