HIVPhase 1IAVI C114NCT06617091
A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.
A Phase 1 study testing GRAdHIVNE1 Vaccine in people with HIV, run by International AIDS Vaccine Initiative at 3 sites in 2 countries.
Trial summary
A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine (GRAdHIVNE1 Vaccine), Administered to Healthy Adults Living without HIV and Living with HIV, in Southern Africa Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- GRAdHIVNE1 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Jul 2025to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.
- All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception from 21 days prior to receiving the IP until 4 months following the last IP administration, including:
- Intrauterine device, or contraceptive implant
- Hormonal contraception
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- Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has [1] documentation of azoospermia by microscopy (< 1 year ago), or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy)
- Women who have undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, as well as those who are postmenopausal (> 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level > 40 IU/L) will not be required to use contraceptives.
- Willing to forgo donations of blood, or any other tissues during the study.
- Additional Inclusion criteria for PLWH
- Confirmed HIV infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing on screening visit.
- CD4 ≥ 500 cells/µl at screening.
- Currently on ART, and documentation of continuous combination ART (cART) for at least 12 months with suppression of plasma HIV-1 viral load < 50 copies / ml for greater than 6 months prior to trial entry, measured on at least 2 independent occasions that can include the screening viral load. cART is defined as a regimen including ≥ 2 compounds, e.g., 2 nucleoside reverse transcriptase inhibitors plus either non-nucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor.
- Viral load < 50 copies / ml at time of screening (within 28 days prior to IP administration).
- Must commit to adhering to a suppressive ART regimen for the duration of the study
Who cannot join
- Any clinically significant acute or chronic medical condition, other than HIV infection (in Part B only), that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study.
- For the PLWH (Part B), history of AIDS-defining illness or CD4 < 200 cells/µl.
- If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance.
- Bleeding disorder that was diagnosed by a physician (e.g., Factor deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.
- 6. History of a splenectomy. 7. Previous receipt of an adenovirus vectored vaccine. 8. Receipt of live attenuated vaccine or other vaccine within the previous 60 days or planned receipt within 180 days after administration of IP. Receipt of blood transfusion or blood derived products within the previous 3 months.
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- 9. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study.
- 10. Prior receipt of an investigational HIV vaccine candidate, monoclonal antibody or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval).
- 11. History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema).
- 12. Psychiatric condition that compromises safety of the participant and precludes compliance with the protocol. Specifically excluded are persons with history of psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
- 13. If, in the opinion of the Principal Investigator or designee, it is not in the best interest of the participant to participate in the trial.
- 14. Seizure disorder: a participant who has had a seizure in the last 3 years is excluded. (Not excluded: a participant with a history of seizures who has neither required medications nor had a seizure for 3 years.) 15. Infectious disease: chronic hepatitis B infection (HbsAg positive), current hepatitis C infection (HCV Ab positive and/ or HCV RNA) or treatment for hepatitis C infection in the past year, or active syphilis (RPR confirmed by TPHA).
- 16. A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy.
- 17. Active, serious infections (other than HIV infection in PLWH) requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment.
- 18. Any abnormal laboratory parameters at screening per protocol. 19. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease, other than HIV among the PLWH; use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the investigator within the previous 6 months.
- Eligibility Criteria Specific to PLWoH (Part A) People living without HIV(PLWoH) at screening, must be deemed to be at low risk of HIV infection and willing to maintain low-risk behavior for the duration of the trial.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
South Africa2 sites, 2 recruiting
- Recruiting
DTHF
Cape Town, Western Cape
- Recruiting
AHRI
Mtubatuba, KwaZulu-Natal
About this study
Official title: A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without HIV and Living With HIV, in Southern Africa
A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine (GRAdHIVNE1 Vaccine), Administered to Healthy Adults Living without HIV and Living with HIV, in Southern Africa
Read the detailed description
This is a Phase 1 trial for the GRAdHIVNE1 vaccine, designed to evaluate safety, tolerability, and immunogenicity in healthy individuals (PLWoH) including healthy People Living with HIV (PLWH). This study builds on insights from prior T-cell vaccine trials and pre-clinical non-human primate studies, which demonstrated that robust CD8+ T cell responses, are crucial for viral control but require broad, polyfunctional responses that can also effectively counteract HIV's diversity and immune evasion strategies. Inclusion of PLWoH and PLWH in this study is important for safety, tolerability and immunogenicity data that can inform further development of the vaccine for prevention and therapeutic use. Prior clinical trials, using adenovirus vectors and exploring different vaccine approaches, demonstrated safety and potential immunogenic benefits in PLWH, despite not achieving sustained viral suppression post-treatment interruption Understanding these dynamics is key to evaluating the full therapeutic potential of vaccine induced immune responses in controlling HIV as well as inform the potential of the vaccine in aborting the establishment of a disseminated infection in the setting of prevention.
- Conditions
- HIV
- Being tested
- GRAdHIVNE1 Vaccine, Placebo
- Keywords
- GRAdHIVNE1 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRAdHIVNE1 VaccineDrug
Also called gorilla-isolated adenovirus (GRAd32) vector
This is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.
PlaceboOther
This is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV (PLWH) and People living without HIV (PLWoH) | Experimental | Participants living without HIV (PLWoH) will be assigned to receive either a single dose, 2 doses of the GRAdHIVNE1 vaccine, or placebo. Participants living with HIV (PLWH) will be assigned to receive either 2 doses of the GRAdHIVNE1 vaccine, or placebo.
Each participant is to receive GRAdHIVNE1 at vaccine dose 5x10^10 or 2x10^11 or to receive placebo. Receives: Drug: GRAdHIVNE1 Vaccine |
| Placebo NaCl for injection | Placebo comparator | Participants living without HIV (PLWoH) will be assigned to receive either a single dose, 2 doses of the GRAdHIVNE1 vaccine, or placebo. Participants living with HIV (PLWH) will be assigned to receive either 2 doses of the GRAdHIVNE1 vaccine, or placebo.
Each participant is to receive GRAdHIVNE1 at vaccine dose 5x10^10 or 2x10^11 or to receive placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety and tolerability of GRAdHIVNE1 vaccine
- Proportion of participants with each type of reactogenicity event classified by severity of the events from initial administration through 7 days following completion of each dose of the investigational product.
Measured: 7 Day
Assessment of unsolicited adverse events (AEs)
Proportion of participants reporting unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, classified by severity and causality, from initial administration through 28 days following completion of each dose of the investigational product.
Measured: 28 day
Assessment of SAEs
Proportion of participants reporting serious adverse events (SAEs) throughout the study period, classified by causality.
Measured: 19 months
Secondary outcomes (7)
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
- Response rate and magnitude of the vaccine induced HIV specific T cell response at peak immunogenicity as measured by intracellular cytokine staining assay or IFNγ ELISpot assay after each dose.
Measured: 19 Months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To assess antigen specific proliferative memory T cell responses induced by vaccination.
Measured: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To identify immunogenic epitopes within the vaccine immunogen and define the HLA restriction.
Measured: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To define the functional characteristics of antigen specific T cells by assessing proliferation, cytotoxicity, tetramer analysis and TCR sequences.
Measured: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To evaluate vaccine induced innate immune responses.
Measured: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To characterize vaccine induced de novo T-cell responses compared to pre-existing responses in PLWH (Part B).
Measured: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To conduct analyses to further understand HIV and vaccine immunology
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start28 Jul 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International AIDS Vaccine Initiative
- Sponsor type
- Research network
- Collaborators
- Ragon Institute, ReiThera Srl, Mutala Trust
- Responsible party
- Sponsor
- Investigators
- Theodorah Ndzhukule, Principal investigator, Desmond Tutu Health FoundationLimakatso Lebina, Principal investigator, Africa Health Research Institute (AHRI)Tariro Makadzange, Principal investigator, Mutala Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617091
- Sponsor's protocol ID
- IAVI C114
- Acronym
- IAVI C114
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full data package will be made available to the public approximately 12 months after the trial Completion. To protect participant privacy the data package will be sent to a company who specializes in anonymization and pseudonymization of clinical trial data that will strip out or anonymize any potential identifying information such as participant IDs, dates of birth, initials, visit dates, or any other data that alone or in aggregate could identify an individual.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without HIV and Living With HIV, in Southern Africa
- ClinicalTrials.gov ID
- NCT06617091
- Acronym / sponsor ID
- IAVI C114 / IAVI C114
- Conditions
- HIV
- Keywords
- GRAdHIVNE1 Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- International AIDS Vaccine InitiativeResearch network
- Collaborators
- Ragon Institute, ReiThera Srl, Mutala Trust
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Sep 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.
A Phase 1 Randomized Double Blinded Placebo Controlled, Dose Ranging Trial, of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine (GRAdHIVNE1 Vaccine), Administered to Healthy Adults Living without HIV and Living with HIV, in Southern Africa
Detailed description
This is a Phase 1 trial for the GRAdHIVNE1 vaccine, designed to evaluate safety, tolerability, and immunogenicity in healthy individuals (PLWoH) including healthy People Living with HIV (PLWH). This study builds on insights from prior T-cell vaccine trials and pre-clinical non-human primate studies, which demonstrated that robust CD8+ T cell responses, are crucial for viral control but require broad, polyfunctional responses that can also effectively counteract HIV's diversity and immune evasion strategies. Inclusion of PLWoH and PLWH in this study is important for safety, tolerability and immunogenicity data that can inform further development of the vaccine for prevention and therapeutic use. Prior clinical trials, using adenovirus vectors and exploring different vaccine approaches, demonstrated safety and potential immunogenic benefits in PLWH, despite not achieving sustained viral suppression post-treatment interruption Understanding these dynamics is key to evaluating the full therapeutic potential of vaccine induced immune responses in controlling HIV as well as inform the potential of the vaccine in aborting the establishment of a disseminated infection in the setting of prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with HIV (PLWH) and People living without HIV (PLWoH) | Experimental | Drug: GRAdHIVNE1 VaccineParticipants living without HIV (PLWoH) will be assigned to receive either a single dose, 2 doses of the GRAdHIVNE1 vaccine, or placebo. Participants living with HIV (PLWH) will be assigned to receive either 2 doses of the GRAdHIVNE1 vaccine, or placebo. Each participant is to receive GRAdHIVNE1 at vaccine dose 5x10^10 or 2x10^11 or to receive placebo. |
| Placebo NaCl for injection | Placebo comparator | Other: PlaceboParticipants living without HIV (PLWoH) will be assigned to receive either a single dose, 2 doses of the GRAdHIVNE1 vaccine, or placebo. Participants living with HIV (PLWH) will be assigned to receive either 2 doses of the GRAdHIVNE1 vaccine, or placebo. Each participant is to receive GRAdHIVNE1 at vaccine dose 5x10^10 or 2x10^11 or to receive placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.
- All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception from 21 days prior to receiving the IP until 4 months following the last IP administration, including:
- Women who have undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, as well as those who are postmenopausal (> 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level > 40 IU/L) will not be required to use contraceptives.
Key exclusion criteria (16 listed)
- Any clinically significant acute or chronic medical condition, other than HIV infection (in Part B only), that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study.
- For the PLWH (Part B), history of AIDS-defining illness or CD4 < 200 cells/µl.
- If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance.
- Bleeding disorder that was diagnosed by a physician (e.g., Factor deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.
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 |
|---|---|---|
| GRAdHIVNE1 VaccineAlso: gorilla-isolated adenovirus (GRAd32) vectorThis is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups. | Drug | People living with HIV (PLWH) and People living without HIV (PLWoH) |
| PlaceboThis is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups. | Other | Placebo NaCl for injection |
Primary outcome
Assess safety and tolerability of GRAdHIVNE1 vaccine
Time frame: 7 Day
1. Proportion of participants with each type of reactogenicity event classified by severity of the events from initial administration through 7 days following completion of each dose of the investigational product.
Assessment of unsolicited adverse events (AEs)
Time frame: 28 day
Proportion of participants reporting unsolicited adverse events (AEs), including safety laboratory (biochemical, hematological) parameters, classified by severity and causality, from initial administration through 28 days following completion of each dose of the investigational product.
Assessment of SAEs
Time frame: 19 months
Proportion of participants reporting serious adverse events (SAEs) throughout the study period, classified by causality.
7 secondary outcomes
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
Time frame: 19 Months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
Time frame: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
Time frame: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
Time frame: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
Time frame: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
Time frame: 19 months
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
Time frame: 19 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. The full data package will be made available to the public approximately 12 months after the trial Completion. To protect participant privacy the data package will be sent to a company who specializes in anonymization and pseudonymization of clinical trial data that will strip out or anonymize any potential identifying information such as participant IDs, dates of birth, initials, visit dates, or any other data that alone or in aggregate could identify an individual.
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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.
Theodorah Ndzhukule principal investigator
Desmond Tutu Health Foundation
Limakatso Lebina principal investigator
Africa Health Research Institute (AHRI)
Tariro Makadzange principal investigator
Mutala Trust
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRAdHIVNE1 Vaccine in people with HIV, run by International AIDS Vaccine Initiative at 3 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 15 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa, Zimbabwe. 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?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Muturi-Kioi, MBChB (+254-71-904-3151, VMuturi-Kioi@iavi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety and tolerability of GRAdHIVNE1 vaccine (time frame: 7 Day). 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 13 Feb 2026.