Trial Outcomes & Findings for HIV-1 Peptide Immunisation of Individuals in West Africa to Prevent Disease (NCT NCT01141205)

NCT ID: NCT01141205

Last Updated: 2013-08-08

Results Overview

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".

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 18 participants
• Primary outcome timeframe: up to 6 months after end of treatment
• Results posted on: 2013-08-08

Participant Flow

medical clinic

Participant milestones

Measure	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
Overall Study STARTED	18	5
Overall Study COMPLETED	15	3
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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
Overall Study Physician Decision	1	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	AFO-18 n=18 Participants 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)	Saline n=5 Participants Saline injection	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	5 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	34 years STANDARD_DEVIATION 2 • n=5 Participants	29 years STANDARD_DEVIATION 2 • n=7 Participants	32 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	3 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Guinea-Bissau	18 participants n=5 Participants	5 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months after end of treatment

Population: 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

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".

Outcome measures

Measure	Vaccinee n=16 Participants participants receiving active peptide in CAF01 adjuvants vaccine	Placebo n=4 Participants participants receiving saline
Tolerability and Safety of the Treatment.	0 participants	0 participants

SECONDARY outcome

Timeframe: up to 6 months after last immunisation

Population: 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

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).

Outcome measures

Measure	Vaccinee n=14 Participants participants receiving active peptide in CAF01 adjuvants vaccine	Placebo n=2 Participants participants receiving saline
Induction of New T-cell Immune Response by the Vaccine	6 ELISPOT responders	0 ELISPOT responders

SECONDARY outcome

Timeframe: up to 6 months post immunization

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

changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log

Outcome measures

Measure	Vaccinee n=15 Participants participants receiving active peptide in CAF01 adjuvants vaccine	Placebo n=3 Participants participants receiving saline
Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log	0 participants with lowering of VL	0 participants with lowering of VL

SECONDARY outcome

Timeframe: up to 6 months post vaccination

Population: Participants minus drop-outs and withdrawn participants

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

Outcome measures

Measure	Vaccinee n=15 Participants participants receiving active peptide in CAF01 adjuvants vaccine	Placebo n=3 Participants participants receiving saline
Increase in Blood CD4 T-cell Counts	0 participants with increased CD4 count	0 participants with increased CD4 count

Adverse Events

AFO-18

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	AFO-18 n=18 participants at risk 18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)	Saline n=5 participants at risk Saline injection
Infections and infestations Died of pneumonia	5.6% 1/18 • Number of events 1 • 6 months One participant in the vaccinee group of 18 individuals had a SAE (serious infection) not related to the vaccine. One participant in the saline placebo group of 5 individuals experienced a SAE (increase in liver enzymes) not related to the placebo saline. None others experienced any AE was noted.	0.00% 0/5 • 6 months One participant in the vaccinee group of 18 individuals had a SAE (serious infection) not related to the vaccine. One participant in the saline placebo group of 5 individuals experienced a SAE (increase in liver enzymes) not related to the placebo saline. None others experienced any AE was noted.
Infections and infestations Increase in liver enzymes	0.00% 0/18 • 6 months One participant in the vaccinee group of 18 individuals had a SAE (serious infection) not related to the vaccine. One participant in the saline placebo group of 5 individuals experienced a SAE (increase in liver enzymes) not related to the placebo saline. None others experienced any AE was noted.	20.0% 1/5 • Number of events 1 • 6 months One participant in the vaccinee group of 18 individuals had a SAE (serious infection) not related to the vaccine. One participant in the saline placebo group of 5 individuals experienced a SAE (increase in liver enzymes) not related to the placebo saline. None others experienced any AE was noted.

Other adverse events

Adverse event data not reported

Additional Information

Dr Anders Fomsgaard

Statens Serum Institut

Phone: +45-32683460

Email: afo@ssi.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place