Aids, Cdc Group IPhase 1HIV-BISNCT01141205
HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
A Phase 1 study testing AFO-18 and Saline in people with Aids, Cdc Group I, run by Statens Serum Institut at 2 sites in Guinea-Bissau.
Trial summary
Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular immunity against HIV-1. Target group: Untreated healthy individuals with chronic HIV-1 infection. Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Aids, Cdc Group I
- What is being tested?
- AFO-18 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesGuinea-Bissau
- Study dates
- Aug 2009to Jun 2012
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-1 seropositive with measurable viral load >10e3 copies/ml and CD4+ T-cell count >400 CD4+ cells/µl.
- Not in Antiretroviral Therapy (>1 year).
- Male or female with age between 18 and 50 years.
- Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (e.g. white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin
- Expected to follow the instructions.
- Written informed consent after oral and written information.
Who cannot join
- Vaccinated with other vaccines within 3 months before the first vaccination.
- Treated with immune modulating medicine within 3 month before the first immunization.
- Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB
- Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.
- Severe allergy or earlier anaphylactic reactions.
- Active autoimmune diseases.
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- Simultaneous treatment with other experimental drugs.
- Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Guinea-Bissau2 sites
Hospital Nacional Simao Mendes
Bissau, Guinea-Bissau
Hospital Nacional Simao Mendes
Bissau
About this study
Official title: Phase I Study: HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease
Treatment: Immunization with peptide-mix and adjuvant. The vaccine should induce cellular immunity against HIV-1.
Target group: Untreated healthy individuals with chronic HIV-1 infection.
Read more
Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.
The secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of immunity, lowering of viral load, induction of escape mutations in the virus and improvement in the patient CD4 lymphocyte blood counts.
The third purpose is to evaluate the feasibility of conducting a therapeutic HIV immunization study in a poorly-resourced African setting.
Design: The experiment is designed as a blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in West Africa.
Numbers of individuals: Phase I: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls).
Read the detailed description
The HIV infection does not leave lifelong immunity, but leads to break down of the immune system, opportunistic infections and death. The immunity obtained by the infection itself can only partially contain the HIV infection. The purpose with a targeted therapeutic vaccination is therefore in addition to the existing immunity to induce a broader, more powerful and more rationally or better directed immunity than the one induced by the "natural" HIV-1 infection. This would potentially lower the viral load in the blood making it more difficult to spread the virus to others and prolong the time to AIDS disease and medical treatment. There is a need for new rational vaccination possibilities, able to prevent (HIV) disease, postpone the need for antiretroviral medical treatment, prolong the life, and limit spread of HIV-1 in the population. The present protocol seak to introduce such a new immune treatment principle for HIV-1 infected individuals. In this study, individuals with chronic HIV-1 infection will be vaccinated with selected synthetic HIV immune-peptides representing new discovered conserved target´s on the virus. The vaccine should induce new immunity against several epitope targets on their HIV, whereby the HIV infection may be controlled for a longer time by the immune system. The purpose of the study is primarily to evaluate the safety and tolerability of the vaccine and secondary to evaluate the immunological and antiviral response in the vaccinated individuals.
- Conditions
- Aids, Cdc Group I
- Being tested
- AFO-18, Saline
- Keywords
- AIDS vaccines, HIV-1 vaccine, Therapeutic vaccine, Cellular immunity
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFO-18Biological
Also called CAF01, HIV-1 peptides
18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
SalineDrug
Also called NaCl
1.2 ml saline intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| AFO-18 | Experimental | 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01) Receives: Biological: AFO-18 |
| Saline | Placebo comparator | Saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and Safety of the Treatment.
We report here the numbers of participants with vaccine related adverse events degree 3 or 4.
Our goal for safety and tolerability was: "Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4".
Measured: up to 6 months after end of treatment
Secondary outcomes (3)
Induction of New T-cell Immune Response by the Vaccine
induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (> 50 sfu/mio PBMC).
Measured: up to 6 months after last immunisation
Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log
changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log
Measured: up to 6 months post immunization
Increase in Blood CD4 T-cell Counts
Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of >100 CD4 Tcell per microliter
Measured: up to 6 months post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aids, Cdc Group IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of the Interior and Health, Denmark, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Principal investigator, Anders Fomsgaard, Statens Serum Institut
- Investigators
- Anders Fomsgaard, DMSc, Study director, Statens Serum InstitutZacarias Jose da Silva, PhD, Principal investigator, Bandim Health Project, Bissau, Guinea-Bissau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141205
- Sponsor's protocol ID
- HIV-BIS NCP03/2009
- Other IDs
- EDCTP_MSI.2009.10800.001
- Acronym
- HIV-BIS
- Status last verified
- Aug 2013
- First submitted
- 9 Jun 2010
- Last updated
- 8 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Roman VR, Jensen KJ, Jensen SS, Leo-Hansen C, Jespersen S, da Silva Te D, Rodrigues CM, Janitzek CM, Vinner L, Katzenstein TL, Andersen P, Kromann I, Andreasen LV, Karlsson I, Fomsgaard A. Therapeutic vaccination using cationic liposome-adjuvanted HIV type 1 peptides representing HLA-supertype-restricted subdominant T cell epitopes: safety, immunogenicity, and feasibility in Guinea-Bissau. AIDS Res Hum Retroviruses. 2013 Nov;29(11):1504-12. doi: 10.1089/AID.2013.0076. Epub 2013 Jun 21.
PubMed 23634822