A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted with MPLA Liposomes, in Healthy, HIV-Uninfected Adults
- Conditions
- HIV infectionHIV/AIDS10047438
- Registration Number
- NL-OMON48531
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Proportion of volunteers with a >= grade 3 adverse event, from the day of<br /><br>each vaccination up to 7 days post each vaccination.<br /><br>2. Proportion of volunteers with >= grade 3 and/or vaccine related adverse<br /><br>events, including safety laboratory (biochemical, haematological) parameters,<br /><br>from the day of each vaccination up to 28 days post each vaccination.<br /><br>3. Proportion of volunteers with vaccine-related serious adverse events<br /><br>throughout the study period.</p><br>
- Secondary Outcome Measures
Name Time Method