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
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.
Intrauterine device, or contraceptive implant
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.
Parallel
GRAdHIVNE1 Vaccine
DrugThis is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.
Placebo
Other interventionThis is a dose ranging study that will allow for simultaneous enrollment of participants in both low and high dose groups.
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.
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.
Assessment of SAEs
Proportion of participants reporting serious adverse events (SAEs) throughout the study period, classified by causality.
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
1\. 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.
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To assess antigen specific proliferative memory T cell responses induced by vaccination.
To evaluate cellular immune responses elicited by GRAdHIVNE1 vaccine.
To identify immunogenic epitopes within the vaccine immunogen and define the HLA restriction.
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.
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International AIDS Vaccine Initiative
Lead sponsor
Ragon Institute
Collaborator
ReiThera Srl
Collaborator
Mutala Trust
Collaborator