HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease (HIV-BIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01141205
Recruitment Status : Completed
First Posted : June 10, 2010
Results First Posted : October 15, 2012
Last Update Posted : August 8, 2013
Ministry of the Interior and Health, Denmark
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
Anders Fomsgaard, Statens Serum Institut

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Aids, Cdc Group I
Interventions: Biological: AFO-18
Drug: Saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
AFO-18 18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8
Saline Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8

Participant Flow:   Overall Study
    AFO-18   Saline
STARTED   18   5 
COMPLETED   15   3 
Physician Decision                1                1 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
AFO-18 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
Saline Saline injection
Total Total of all reporting groups

Baseline Measures
   AFO-18   Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   5   23 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   18   5   23 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 34  (2)   29  (2)   32  (2) 
[Units: Participants]
Female   17   3   20 
Male   1   2   3 
Region of Enrollment 
[Units: Participants]
Guinea-Bissau   18   5   23 

  Outcome Measures

1.  Primary:   Tolerability and Safety of the Treatment.   [ Time Frame: up to 6 months after end of treatment ]

2.  Secondary:   Induction of New T-cell Immune Response by the Vaccine   [ Time Frame: up to 6 months after last immunisation ]

3.  Secondary:   Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log   [ Time Frame: up to 6 months post immunization ]

4.  Secondary:   Increase in Blood CD4 T-cell Counts   [ Time Frame: up to 6 months post vaccination ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr Anders Fomsgaard
Organization: Statens Serum Institut
phone: +45-32683460

Publications of Results:

Responsible Party: Anders Fomsgaard, Statens Serum Institut Identifier: NCT01141205     History of Changes
Other Study ID Numbers: HIV-BIS NCP03/2009
EDCTP_MSI.2009.10800.001 ( Other Grant/Funding Number: EDCTP_MSI.2009.10800.001 )
First Submitted: June 9, 2010
First Posted: June 10, 2010
Results First Submitted: June 13, 2012
Results First Posted: October 15, 2012
Last Update Posted: August 8, 2013