AIDS/HIV - RelatedDisease Associated With AIDSEarly Phase 1NCT06541093

Study to Evaluate the Safety and Immunogenicity of an HIV-1 Vaccine Regimen of Adjuvanted UVAX-1107 Followed by Adjuvanted UVAX-1107 or Adjuvanted UVAX-1197 in Healthy Subjects Aged 25-55 Years.

A Early Phase 1 study testing UVAX-1107 and UVAX-1197 in people with AIDS/HIV - RelatedDisease Associated With AIDS and Vaccine-Preventable Diseases, run by Uvax Bio LLC at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: AIDS/HIV - RelatedDisease Associated With AIDS, Vaccine-Preventable Diseases, HIV Infections
What is being tested?: UVAX-1107 and UVAX-1197
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteAustralia
Study dates: 30 Jan 2024to 21 Mar 2025
Phase: Early Phase 1
Are there results?: None posted in the registry

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 25 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female, 25-55 years of age, inclusive, at screening.
Stable health status, as established by physical examination and medical history.
Capable of providing written informed consent.
Female participants of reproductive potential must be non-pregnant and non lactating, and if of child-bearing potential must agree to be heterosexually inactive from at least 21 days prior to enrolment (Day 1)and through 90 days following last study vaccination or agrees to consistently use highly effective method of birth control and refrain from donating oocytes from at least 21 days prior to enrolment and through 90 days following last study vaccination.
Male participants must:
Agree not to donate sperm from the time of signing consent until at least 90 days after the last dose of study drug.
If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception until at least 90 days after the last dose of study drug.
If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom.

Who cannot join

Chronic illness being treated actively and with evidence of recent adjustments in medications for worsening or fluctuating symptoms in the past 3 months, or hospitalizations / procedural interventions in the past 6 months.
Body mass index (BMI) of less than 17 and greater than 32 kg/m2 at screening.
Vital signs grading greater than 1 at screening
Toxicity grading greater than 1 for screening laboratory test results.
Any abnormal, clinically significant ECG result at screening.
High risk of contracting HIV.

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History of cancer (malignancy) in the last 10 years.
Use of narcotic/illicit drugs or a history of drug/alcohol abuse within the past 2 years.
Has donated blood or suffered from blood loss of more than 450 mL (1 unit of blood) within 60 days prior to screening, or donated plasma within 14 days prior to screening.
Receipt of immunoglobulin, blood-derived products, high dose systemic corticosteroids, or other immunosuppressant drugs within 90 days prior to Day 1 or who expect to receive immunoglobulin or another blood product during the study.
Receipt of a licensed or emergency/provisional approval vaccine within the last 30 days prior to Day 1.
Known hypersensitivity to any component of the study vaccines, including history of anaphylaxis or other significant allergy in the opinion of the Investigator.
Any autoimmune or immunodeficiency disease/condition (inherited or iatrogenic) or chronic hematologic disorder (anemia, sickle cell, thalassemia).
Evidence of HIV, positive hepatitis B surface antigen or core antibody or hepatitis C antibodies by screening test.
Any chronic or degenerative neurological disease or history of significant neurological disorder.
Evidence of cardiovascular, pulmonary, renal, hepatobiliary disease or any other baseline condition (history and medication review) that has required active treatment or intervention.
Evidence of major depression disorder not well controlled in the past 2 years or history of suicidal ideation or attempt in the past 2 years.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Network Melbourne
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: Phase 1 Proof-of-Concept Study to Evaluate the Safety and Immunogenicity of a Priming VaccinationRegimen of Uvax Bio's Glycan Trimmed HIV-1 Vaccine (UVAX-1107) With CpG 1018®/Aluminum HydroxideAdjuvant in Healthy Adults (25-55 Years), Followed by Boosting Vaccination Regimen Using UVAX-1107 orWildtype Non-Glycan Trimmed HIV-1 Vaccine (UVAX-1197) With CpG 1018®/Aluminum Hydroxide Adjuvant

This is a first in human testing of novel HIV-1 protein nanoparticles vaccine candidates, UVAX-1107 and UVAX-1197 mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants. After meeting all eligibility criteria, approximately 34 participants will receive a 4-dose vaccination regimen of either 2 priming vaccinations of UVAX-1107 followed by 2 boosting vaccinations of UVAX-1197, or 4 doses of UVAX-1107, or placebo. Subject participation is expected to last up to 374 days, including up to a 30-day screening period and a 337-day study period during which subjects will be followed for safety and immunogenicity outcomes.

Read the detailed description

This is a first in human testing of a novel HIV-1 vaccine candidate. Both UVAX-1197 and UVAX-1107 are protein nanoparticle vaccines displaying an uncleaved, prefusion-optimized (UFO) envelope (Env) glycoprotein from HIV-1 BG505 (BG505-UFO). The UVAX-1197 displays fully glycosylated UFO Env trimers with wildtype glycans (WT). UVAX-1107 is derived from UVAX-1197 by enzymatic "glycan trimming" (GT) of N-linked glycans in order to better expose major neutralizing epitopes on the surface of BG505-UFO Env to immune recognition. The optimized vaccine immunogens will be mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants to enhance the immune response. Subject participation is expected to last up to 374 days, including up to a 30-day screening period and a 337-day study period.

Part 1 of the study will be a safety lead-in cohort in which 4 participants will receive 2 priming vaccinations of a half dose of adjuvanted UVAX-1107 (administered in 0.5ml intramuscular injection) on Days 1 and 57 followed by boosting vaccinations of a half dose of adjuvanted UVAX-1197 on Days 141 and 225, administered as intra-muscular (IM) injections. Safety will be reviewed after subjects in Part 1 reach Day 8, prior to opening Part 2.

A separate group of participants will be enrolled in Part 2 of the study. Participants in Part 2 will be randomized to the following treatment arms to receive either:

Priming vaccinations of adjuvanted UVAX-1107 (full dose, administered in 0.5ml intramuscular injection) on Days 1 and 57 followed by boosting vaccinations of adjuvanted UVAX-1197 (full dose, administered in 0.5ml intramuscular injection) on Days 141 and 225.
Priming vaccinations of adjuvanted UVAX-1107 (full dose) on Days 1 and 57 followed by boosting vaccinations of adjuvated UVAX-1107 (full dose) on Days 141 and 225.

When Part 2 of the study opens, 5 sentinel participants (2 from each of the active treatment groups and 1 from the placebo group) will be randomized. Safety will be reviewed after these first 5 Part 2 participants reach Day 8 prior to opening randomization to the remaining participants in Part 2.

Vaccinations will be administered by trained staff at the study site(s) according to site's SOPs. Details regarding dosing, including the dose administered, arm, and the date and time of dosing, will be recorded in the subjects source notes and electronic case report form (eCRF).

Conditions: AIDS/HIV - RelatedDisease Associated With AIDS, Vaccine-Preventable Diseases, HIV Infections
Being tested: UVAX-1107, UVAX-1197, Placebo
Keywords: Vaccine, HIV, AIDS, Prevention
Medical subject headings: Vaccine-Preventable Diseases, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UVAX-1107Biological
Novel HIV-1 protein nanoparticles vaccine candidate (WT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants
UVAX-1197Biological
Novel HIV-1 protein nanoparticles vaccine candidate (GT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants
PlaceboOther
Saline injection

Study groups in NCT06541093
Study group	Role	What they receive
UVAX-1107 half dose + UVAX-1197 half dose boost	Experimental	Not described Receives: Biological: UVAX-1107; Biological: UVAX-1197
UVAX-1107 full dose + UVAX-1197 full dose boost	Experimental	Not described Receives: Biological: UVAX-1107; Biological: UVAX-1197
UVAX-1107 full dose + UVAX-1107 full dose boost	Experimental	Not described Receives: Biological: UVAX-1107
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess local and systemic reactogenicity following vaccination (Day 1 to Day 8, inclusive) following each vaccination.
Reactogenicity (local and systemic) will be recorded by the subject using a daily diary after vaccination andfor 6 consecutive days thereafter.
Measured: Days 1 through Day 7 after each vaccination.
To determine if antibody responses are induced at 2 weeks after each vaccination using anti-HIV-1 protein IgG.
Serum samples will be collected at specified timepoints for HIV-1-specific IgG titers
Measured: Pre-vaccination timepoints (Day 1, Day 57, Day 141 and Day 225) and ~2 weeks after each vaccination (Day15, Day 71, Day 155 and Day 239) and Day 337 post enrolment/End of study (EOS).

Secondary outcomes (7)

To assess serious adverse events (SAEs) or adverse events of special interest (AESI) attributed to vaccination.
As the proposed trial (UVAX-HIV-101) will be the first study of UVAX-1197 and -1107 in humans, there is currently no data regarding AEs associated with either UVAX-1197 or -1107 in humans. UVAX-1197 and -1107 have been administered in animals without significant adverse reactions being observed. Based on preclinical experience and AEs generally observed in other intramuscular administered vaccines using a similar development platform, the vaccinations are expected to result in mild to moderate local reactions and/or systemic reactions. These AEs will be assessed via clinical examination at the reference timepoints and via the use of a subject diary for the 7 days following each vaccination.
Measured: At all visits, Day 1, Day 8, Day 15, Day 29, Day 57, Day 64, Day 71, Day 85, Day 141, Day 148, Day 156, Day 169,Day 225, Day 232, Day 239, Day 253 and Day 337 post enrolment/End of Study (EOS).
To describe occurrence of Medically Attended Adverse Events (MAAEs).
MAAEs (e.g. any AEs that are evaluated by a healthcare professional either at the site or within the community) will be reported from Day 1 through 28 days after the last vaccination was received. They will be assessed using study-specific questionnaire, clinical examination and data-linkage to medical records. These AEs will be assessed via clinical examination at the reference timepoints and via the use of a subject diary for the 7 days following each vaccination.
Measured: On pre- and post-dose Day 1, Day 8, Day 15, Day 29, pre- and post-dose Day 57, Day 64, Day 71, Day 85,pre- and post-dose Day 141, Day 148, Day 156, Day 169, pre- and post-dose Day 225, Day 232, and Day 253
To describe occurrence of treatment emergent adverse events (TEAEs)
TEAEs (e.g. any AEs that occur after the study product has been administered) will be reported throughout the study period until Day 253 (28 days following the last dose) .They will be assessed, using study-specific questionnaire, clinical examination and data-linkage to medical records. These AEs will be assessed via clinical examination at the reference timepoints and via the use of a subject diary for the 7 days following each vaccination
Measured: Endpoint will evaluate TEAEs reported until Day 29 following each vaccination (Day 1, Day 8, Day 15, Day 29,post-dose Day 57, Day 64, Day 71, Day 85, post-dose Day 141, Day 148, Day 156, Day 169, post-dose Day225, Day 232, and Day 253).
To describe occurrence of laboratory-related adverse events from pre-vaccination to 7 days following each vaccination.
Clinically significant abnormal laboratory values for chemistry, hematology and bleeding indices will be graded according to the FDA toxicity scale, or CTCAE if not graded within the FDA scale, and recorded as an AE.
Measured: Screening visit, Day 8, pre-dose Day 57, Day 64, pre-dose Day 141, day 148, pre-dose Day 225, Day 239 and Day 337 post-enrolment/End of Study (EOS)
To describe occurrence of adverse events from vital sign measurements following each vaccination.
Vital signs assessments will include oral temperature (degrees C) using an oral/tympanic thermometer, respiratory rate (breaths per minute) using manual assessment of breaths, systolic and diastolic blood pressure (mmHg) and heart rate (bpm) using a digital blood pressure machine. Clinically significant abnormal vital sign measurements will be graded according to the FDA toxicity scale, or CTCAE if not graded within the FDA scale, and recorded as an AE.
Measured: All study visits (Screening, pre- and post-dose Day 1, Day 8, Day 15, Day 29, pre- and post-dose Day 57, Day64, Day 71, Day 85, pre- and post-dose Day 141, Day 148, Day 156, Day 169, pre- and post-dose Day 225, Day232, Day 253 and Day 337.
To determine difference in autologous neutralizing antibody response across dose groups
Serum will be collected for assessment of occurrence and level of HIV-1-specifi c neutralization titers against vaccine neutralization titers against select Tier 2 panels
Measured: Pre-vaccinations timepoints (Day 1, Day 57, Day 141 and Day 225), and ~2 weeks after each vaccination (Day15, Day 71, Day 155, and Day 239) and at the EOS (Day 337 post-enrolment).
To determine difference in heterologous neutralizing antibody response across dose groups
Serum will be collected for assessment of occurrence and level of HIV-1-specific neutralization titers against select Tier 2 panels
Measured: Days 155 and 239. Conditional testing at timepoints (Day 1, Day 57, Day 141 and Day 225), and remaining post-vaccination timepoints (Day 15, Day 71) may be performed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202421 Mar 2025

First posted7 Aug 2024
Study start30 Jan 2024
Primary completion21 Mar 2025
Study completion21 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AIDS/HIV - RelatedDisease Associated With AIDSStudies 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: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06541093
Sponsor's protocol ID: UVAX-HIV-101
Status last verified: May 2025
First submitted: 21 Jun 2024
Last updated: 23 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Proof-of-Concept Study to Evaluate the Safety and Immunogenicity of a Priming VaccinationRegimen of Uvax Bio's Glycan Trimmed HIV-1 Vaccine (UVAX-1107) With CpG 1018®/Aluminum HydroxideAdjuvant in Healthy Adults (25-55 Years), Followed by Boosting Vaccination Regimen Using UVAX-1107 orWildtype Non-Glycan Trimmed HIV-1 Vaccine (UVAX-1197) With CpG 1018®/Aluminum Hydroxide Adjuvant
ClinicalTrials.gov ID: NCT06541093
Acronym / sponsor ID: UVAX-HIV-101
Conditions: AIDS/HIV - RelatedDisease Associated With AIDS, Vaccine-Preventable Diseases, HIV Infections
Keywords: Vaccine, HIV, AIDS, Prevention
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Uvax Bio LLCIndustry (pharma, biotech, devices)
Study start: 30 Jan 2024 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 21 Mar 2025 (actual)
First posted: 7 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A separate group of participants will be enrolled in Part 2 of the study. Participants in Part 2 will be randomized to the following treatment arms to receive either:

Priming vaccinations of adjuvanted UVAX-1107 (full dose, administered in 0.5ml intramuscular injection) on Days 1 and 57 followed by boosting vaccinations of adjuvanted UVAX-1197 (full dose, administered in 0.5ml intramuscular injection) on Days 141 and 225.
Priming vaccinations of adjuvanted UVAX-1107 (full dose) on Days 1 and 57 followed by boosting vaccinations of adjuvated UVAX-1107 (full dose) on Days 141 and 225.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
UVAX-1107 half dose + UVAX-1197 half dose boost	Experimental	Biological: UVAX-1107, Biological: UVAX-1197
UVAX-1107 full dose + UVAX-1197 full dose boost	Experimental	Biological: UVAX-1107, Biological: UVAX-1197
UVAX-1107 full dose + UVAX-1107 full dose boost	Experimental	Biological: UVAX-1107
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Male or female, 25-55 years of age, inclusive, at screening.
Stable health status, as established by physical examination and medical history.
Capable of providing written informed consent.
Female participants of reproductive potential must be non-pregnant and non lactating, and if of child-bearing potential must agree to be heterosexually inactive from at least 21 days prior to enrolment (Day 1)and through 90 days following last study vaccination or agrees to consistently use highly effective method of birth control and refrain from donating oocytes from at least 21 days prior to enrolment and through 90 days following last study vaccination.
Male participants must:

Key exclusion criteria (17 listed)

Chronic illness being treated actively and with evidence of recent adjustments in medications for worsening or fluctuating symptoms in the past 3 months, or hospitalizations / procedural interventions in the past 6 months.
Body mass index (BMI) of less than 17 and greater than 32 kg/m2 at screening.
Vital signs grading greater than 1 at screening
Toxicity grading greater than 1 for screening laboratory test results.
Any abnormal, clinically significant ECG result 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
UVAX-1107Novel HIV-1 protein nanoparticles vaccine candidate (WT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants	Biological	UVAX-1107 full dose + UVAX-1107 full dose boost, UVAX-1107 full dose + UVAX-1197 full dose boost, UVAX-1107 half dose + UVAX-1197 half dose boost
UVAX-1197Novel HIV-1 protein nanoparticles vaccine candidate (GT) mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants	Biological	UVAX-1107 full dose + UVAX-1197 full dose boost, UVAX-1107 half dose + UVAX-1197 half dose boost
PlaceboSaline injection	Other	Placebo

Primary outcome

To assess local and systemic reactogenicity following vaccination (Day 1 to Day 8, inclusive) following each vaccination.
Time frame: Days 1 through Day 7 after each vaccination.
Reactogenicity (local and systemic) will be recorded by the subject using a daily diary after vaccination andfor 6 consecutive days thereafter.
To determine if antibody responses are induced at 2 weeks after each vaccination using anti-HIV-1 protein IgG.
Time frame: Pre-vaccination timepoints (Day 1, Day 57, Day 141 and Day 225) and ~2 weeks after each vaccination (Day15, Day 71, Day 155 and Day 239) and Day 337 post enrolment/End of study (EOS).
Serum samples will be collected at specified timepoints for HIV-1-specific IgG titers

7 secondary outcomes

To assess serious adverse events (SAEs) or adverse events of special interest (AESI) attributed to vaccination.
Time frame: At all visits, Day 1, Day 8, Day 15, Day 29, Day 57, Day 64, Day 71, Day 85, Day 141, Day 148, Day 156, Day 169,Day 225, Day 232, Day 239, Day 253 and Day 337 post enrolment/End of Study (EOS).
To describe occurrence of Medically Attended Adverse Events (MAAEs).
Time frame: On pre- and post-dose Day 1, Day 8, Day 15, Day 29, pre- and post-dose Day 57, Day 64, Day 71, Day 85,pre- and post-dose Day 141, Day 148, Day 156, Day 169, pre- and post-dose Day 225, Day 232, and Day 253
To describe occurrence of treatment emergent adverse events (TEAEs)
Time frame: Endpoint will evaluate TEAEs reported until Day 29 following each vaccination (Day 1, Day 8, Day 15, Day 29,post-dose Day 57, Day 64, Day 71, Day 85, post-dose Day 141, Day 148, Day 156, Day 169, post-dose Day225, Day 232, and Day 253).
To describe occurrence of laboratory-related adverse events from pre-vaccination to 7 days following each vaccination.
Time frame: Screening visit, Day 8, pre-dose Day 57, Day 64, pre-dose Day 141, day 148, pre-dose Day 225, Day 239 and Day 337 post-enrolment/End of Study (EOS)
To describe occurrence of adverse events from vital sign measurements following each vaccination.
Time frame: All study visits (Screening, pre- and post-dose Day 1, Day 8, Day 15, Day 29, pre- and post-dose Day 57, Day64, Day 71, Day 85, pre- and post-dose Day 141, Day 148, Day 156, Day 169, pre- and post-dose Day 225, Day232, Day 253 and Day 337.
To determine difference in autologous neutralizing antibody response across dose groups
Time frame: Pre-vaccinations timepoints (Day 1, Day 57, Day 141 and Day 225), and ~2 weeks after each vaccination (Day15, Day 71, Day 155, and Day 239) and at the EOS (Day 337 post-enrolment).
To determine difference in heterologous neutralizing antibody response across dose groups
Time frame: Days 155 and 239. Conditional testing at timepoints (Day 1, Day 57, Day 141 and Day 225), and remaining post-vaccination timepoints (Day 15, Day 71) may be performed

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing UVAX-1107 and UVAX-1197 in people with AIDS/HIV - RelatedDisease Associated With AIDS and Vaccine-Preventable Diseases, run by Uvax Bio LLC at 1 site in Australia.

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 8 inclusion and 17 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 23 May 2025. 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 Australia. 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To assess local and systemic reactogenicity following vaccination (Day 1 to Day 8, inclusive) following each vaccination. (time frame: Days 1 through Day 7 after each vaccination.). The study lists 2 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 NCT06541093.

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 23 May 2025.