HIV infection HIV/AIDS
Conditions
Interventions
Vaccination will take place at month 0, 2 and 6. Ten participants will receive
100 µg of ConM SOSIP.v7 gp140 at each time point (group A). Ten participants
will receive a one-fifth fractional boosti
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men and women, aged between 18 and 50 years on the day of screening. 2. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. 3. Willing and able to give written informed consent. 4. Willing to undergo HIV testing, risk reduction counselling and receive HIV test results, including the possibility of vaccine-induced seropositivity (VISP). 5. All individuals engaging in sexual activity that could lead to pregnancy must commit to use of an effective method of contraception for four months following Investigational Medicinal Product administration. 6. All female volunteers must be willing to undergo urine pregnancy tests. 7. Willing to abstain from donating blood, eggs or sperm from the day of first vaccination until at least 3 months after the end of their participation in the trial. 8. All volunteers must be registered with a general practitioner.
Exclusion criteria
Exclusion criteria: 1. Confirmed HIV-1 or HIV-2 infection 2. Self-reported risk for HIV exposure or STIs prior to screening. 3. If female, pregnant or planning a pregnancy during the period of enrolment until four months after the last study vaccination; or lactating. 4. Any clinically relevant medical condition that is considered in the opinion of the investigator to make the volunteer unsuitable for participation in the study (under which underlying haematological disorders, specified infectious diseases, hyposplenia, auto-immune diseases, bleeding disorders, seizure disorders, immunodeficiency, gastrointestinal, hepatic and cardiopulmonary disorders). This also includes a history of malignancy in the past five years (prior to screening) or ongoing malignancy. (Note: A history of a completely excised malignancy that is considered cured is not an exclusion). 5. Receipt of any vaccine within 60 days of vaccination with the Investigational Medicinal Product. 6. Receipt of blood products or blood-derived products within four months of screening. 7. Participation in another clinical trial of an Investigational Medicinal Product currently, within the previous three months or expected participation during this study. Concurrent participation in an observational study, not involving medicinal products and not requiring any blood or tissue sample collection is not an exclusion criterion. 8. Prior receipt of another investigational HIV vaccine or HIV monoclonal antibody (product). (Note: receipt of placebo in a previous HIV vaccine trial will not exclude a volunteer from participation if documentation is available.) 9. Known hypersensitivity to any component of the vaccine formulation used in this trial, or severe or multiple allergies to drugs or pharmaceutical agents. 10. Positive reaction in antinuclear antibody (ANA) screen and/or subsequent anti-dsDNA assessment; or clinically significant immunoglobulin (IgA, IgG or IgM) values. 11. Use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer. Use of corticosteroids, immunosuppressants, chemotherapeutics, anti-tuberculosis or other medications considered significant by the investigator within the previous six months. Specified exceptions apply. 12. Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of volunteers with a >= grade 3 adverse event, from the day of each vaccination up to 7 days post each vaccination. 2. Proportion of volunteers with >= grade 3 and/or vaccine related adverse events, including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination. 3. Proportion of volunteers with vaccine-related serious adverse events throughout the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Autologous neutralising antibodies induced by ConM SOSIP.v7 gp140 vaccine, adjuvanted in MPLA liposomes: a. Serum titres of autologous neutralising antibodies; b. Proportion of volunteers with autologous neutralising antibodies. 2. Trimer binding antibody responses induced by ConM SOSIP.v7 gp140 vaccine, adjuvanted in MPLA liposomes: a. Magnitude of the trimer binding antibody response; b. Proportion of volunteers with a trimer binding antibody response. 3. Heterologous neutralising antibodies induced by ConM SOSIP.v7 gp140 vaccine, adjuvanted in MPLA liposomes: a. Serum titres of heterologous neutralising antibodies (i.e. against additional (Tier 1a/b, Tier 2) virus strains); b. Proportion of volunteers with heterologous neutralising antibodies. 4. Induction of Env-specific B cell responses will be analysed and comparisons made between individuals with low, high and durable NAb titres (i.e. persistent at 12 and 18 months follow-up): - Env-specific plasmablast repertoire sequence analysis in peripheral blood; - Env-specific germline and memory B cell repertoire sequence analysis in peripheral blood; - Env-specific germinal centre B cell repertoire sequence analysis in the draining lymph node(s). | — |
Countries
Netherlands
Outcome results
None listed