A Trial of a Gorilla Adenovirus Vectored Networked Epitopes Vaccine, Administered to Healthy Adults Living Without and With HIV.

NCT06617091 | Recruiting Phase 1 DMC

• 1 other identifier: IAVI C114
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 3

Brief 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

Conditions

HIV

Keywords

GRAdHIVNE1 Vaccine

Outcome Measures

Primary Outcomes (3)

• Assess safety and tolerability of GRAdHIVNE1 vaccine

  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.

  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.

  28 day

• Assessment of SAEs

  Proportion of participants reporting serious adverse events (SAEs) throughout the study period, classified by causality.

  19 months

Secondary Outcomes (7)

• To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.

  19 Months

• To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.

  19 months

• To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.

  19 months

• To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.

  19 months

• To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.

  19 months

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Placebo OTHER

This is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.

Placebo NaCl for injection

GRAdHIVNE1 Vaccine DRUG

This is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.

Also known as: gorilla-isolated adenovirus (GRAd32) vector

People living with HIV (PLWH) and People living without HIV (PLWoH)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.
• 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

You may not qualify if:

• 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.
• \. 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.
• \. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study.
• \. 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).
• \. History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulties, angioedema).
• \. 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.
• \. 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.
• \. 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).
• \. A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy.
• \. Active, serious infections (other than HIV infection in PLWH) requiring parenteral antibiotic, antiviral or antifungal therapy within 30 days prior to enrollment.
• \. 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.

Sponsors & Collaborators

• Ragon Institute: collaborator
• ReiThera Srl: collaborator
• Mutala Trust: collaborator
• International AIDS Vaccine Initiative: lead

Study Sites (3)

AHRI

Mtubatuba, KwaZulu-Natal, South Africa

RECRUITING

DTHF

Cape Town, Western Cape, South Africa

RECRUITING

Mutala

Harare, Harare, Zimbabwe

RECRUITING

MeSH Terms

Interventions

Disease Vectors

Intervention Hierarchy (Ancestors)

Disease Transmission, Infectious; Public Health; Environment and Public Health; Chain of Infection; Epidemiologic Methods

Study Officials

• Theodorah Ndzhukule

  Desmond Tutu Health Foundation

  PRINCIPAL INVESTIGATOR

• Limakatso Lebina

  Africa Health Research Institute (AHRI)

  PRINCIPAL INVESTIGATOR

• Tariro Makadzange

  Mutala Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Muturi-Kioi, MBChB

CONTACT

+254-71-904-3151; VMuturi-Kioi@iavi.org

Lebohang Molife, MBChB

CONTACT

+27 76 866 7282; LMolife@iavi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized controlled Double - blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 27, 2024
• Study Start: July 28, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Once the final anonymized data package is available it will be posted to the Vivli data repository platform. Vivli will make data available for researchers for 7 years, unless they are contractually unable to do so.
• Access Criteria: Vivli utilizes an independent peer review process to evaluate the validity of external requests. Criteria include the intended analysis by the requestors, professional credentials of the requestors, and the feasibility of the proposed work based on the data requested. After approval by the peer review board, the requestors must sign a data transfer agreement before the data are provided. The data transfer agreement will require the requestor to specify how the transferred data will be held in secure, controlled access during the analysis interval.

Locations

ZA (2); ZI (1)