NL-OMON48531
Completed
Not Applicable
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 - ACTHIVE-001
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
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
Outcomes
Primary Outcomes
Not specified
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