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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01141205
First received: June 9, 2010
Last updated: August 2, 2013
Last verified: August 2013
History of Changes
Results First Received: June 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Treatment
Condition: Aids, Cdc Group I
Interventions: Biological: AFO-18
Drug: Saline

  Participant Flow
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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
  Description
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 
NOT COMPLETED   3   2 
Physician Decision                1                1 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                1 



  Baseline Characteristics
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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
  Description
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 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   18   5   23 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 34  (2)   29  (2)   32  (2) 
Gender 
[Units: Participants]
 		     
Female   17   3   20 
Male   1   2   3 
Region of Enrollment 
[Units: Participants]
 		     
Guinea-Bissau   18   5   23 


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

Measure Type Primary
Measure Title Tolerability and Safety of the Treatment.
Measure Description

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".
Time Frame up to 6 months after end of treatment  

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.
Analyzed: number of participants started minus individuals lost to follow up or participants that withdraw. Thus we include the two individuals where the physician stopped his/her participation because of SAE not related to the vaccine or to the placebo. Reported: numbers of participants with vaccina related SAE

Reporting Groups
  Description
Vaccinee participants receiving active peptide in CAF01 adjuvants vaccine
Placebo participants receiving saline

Measured Values
   Vaccinee   Placebo 
Participants Analyzed 
[Units: Participants]
 		 16   4 
Tolerability and Safety of the Treatment. 
[Units: Participants]
 		 0   0 

No statistical analysis provided for Tolerability and Safety of the Treatment.



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

Measure Type Secondary
Measure Title Induction of New T-cell Immune Response by the Vaccine
Measure Description 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).
Time Frame up to 6 months after last immunisation  

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.
Analyzed: Participants minus drop-outs and withdrawn participants. Reported: numbers of participants with a new induced ELISPOT Y-cell immune response to the vaccine peptide epitopes

Reporting Groups
  Description
AFO-18 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
Placebo Saline Saline injection

Measured Values
   AFO-18   Placebo Saline 
Participants Analyzed 
[Units: Participants]
 		 14   2 
Induction of New T-cell Immune Response by the Vaccine 
[Units: ELISPOT responders]
 		 6   0 

No statistical analysis provided for Induction of New T-cell Immune Response by the Vaccine



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 ]

Measure Type Secondary
Measure Title Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log
Measure Description changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log
Time Frame up to 6 months post immunization  

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.
Participants minus drop outs and participants withdrawn by them selves or by the physicians

Reporting Groups
  Description
Vaccinee participants receiving active HIV-1 peptide vaccine in CAF01 adjuvant i.m.
Saline Placebo participants receiving sterile saline i.m.

Measured Values
   Vaccinee   Saline 
Participants Analyzed 
[Units: Participants]
 		 15   3 
Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log 
[Units: Participants with lowering of VL]
 		 0   0 

No statistical analysis provided for Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log



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

Measure Type Secondary
Measure Title Increase in Blood CD4 T-cell Counts
Measure Description 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
Time Frame up to 6 months post vaccination  

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.
Participants minus drop-outs and withdrawn participants

Reporting Groups
  Description
Vaccinee participants receiving active peptide in CAF01 adjuvants vaccine
Placebo participants receiving saline

Measured Values
   Vaccinee   Placebo 
Participants Analyzed 
[Units: Participants]
 		 15   3 
Increase in Blood CD4 T-cell Counts 
[Units: Participants with increased CD4 count]
 		 0   0 

No statistical analysis provided for Increase in Blood CD4 T-cell Counts




  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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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
e-mail: afo@ssi.dk


Publications of Results:


Responsible Party: Anders Fomsgaard, Statens Serum Institut
ClinicalTrials.gov 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 )
Study First Received: June 9, 2010
Results First Received: June 13, 2012
Last Updated: August 2, 2013