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
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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.
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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 ]

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2. Secondary:

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

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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 ]

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4. Secondary:

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

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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
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