Immunization with peptide-mix and adjuvant. A vaccine to induce cellular immunity against HIV-1 [retrospectively registered]

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201110000274327
• Date of registration: 02/02/2011
• Primary sponsor: Statens Serum Institut (Helle Bossen Konradsen)
• Public title: Immunization with peptide-mix and adjuvant. A vaccine to induce cellular immunity against HIV-1 [retrospectively registered]
• Scientific title: Immunization with peptide-mix and adjuvant. A vaccine to induce cellular immunity against HIV-1
• Date of first enrolment: 2010-08-17
• Target sample size: 19
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000274327
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation by using procedures such as coin-tossing (notes drawn from a hat),; Allocation was determined by the holder of the sequence who is situated off site,

Countries of recruitment

South Africa

Contacts

• Name: Anders Fomsgaard
• Affiliation: Chief of Molecular Virology Laboratory

• Name: Anders Fomsgaard
• Affiliation: MD, Chielf of Lab / Statens Serum Institut

Key inclusion & exclusion criteria

Inclusion criteria: 1. HIV - 1 seropositive with measurable viral load b 10e3 copies/ml and CD4+Tcell count b 400 CD4+cell/ul
2. Not in Antiretroviral therapy (b1year)
3. male or female aged between 18 - 50 years
4. Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (eg white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin
5. Expected to follow instructions
6. Written informed consent after oral and written information
Exclusion criteria: 1. Vaccinated with other vaccines within 3 months before the first vaccination
2. Treated with immune modulating medicine within 3 months before the first immunization
3. Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2,HBV, HCV adn TB
4. Significant medical disease as judged by the investigators, for example, severe asthma/COLD, badly regulated heart disease, insulin dependent diabete mellitus
5. Severe allergy or earlier analphylactic reactions
6. Active autoimmune disease
7. Simultaneous treatment with other experimental drugs
8. Laboratory parameters outside the 'normal' range for teh area and which are considered clinically significant
9. Pregnancy

Age minimum: 18 Year
Age maximum: 50 Year
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
null

Primary Outcome(s)

Evaluate tolerability and safety of treatment

Safety and tolerability

Secondary Outcome(s)

evaluate the clinical effect measured as induction of new T-cell immune response, lowering of viral load, and increase in the CD4 cell count

immunogenicity

Lowering of HIV RNA viral load

Source(s) of Monetary Support

DANIDA Roal Danish Ministry of Foreign Affairs

Statens Serum Institut

EDCTP