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NCT04842682COMPLETEDanonymous

A Phase I Multicenter Double-blind Placebo Controlled Dose Escalation Trial of an Adjuvanted Anti-CD40 mAb Fused to Env GP140 HIV Clade C ZM-96 (CD40.HIVRI.Env) Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Participants

Sponsor

Source record

ANRS, Emerging Infectious Diseases

Phase

Source record

Phase I

Modality

AI-normalized

protein therapy

Target

AI-normalized

HIV-1 Vaccine

Indication / condition

AI-normalized

Healthy Adults

Intervention

Source record

Solo 0.3 group, Solo 1 group, Solo 3 group, Combi 0.3 group, Combi 1 group, Combi 3 group, Late boost CD40 alone, Late boost CD40 adjuvanted

Source & freshness

Source record

NCT ID

NCT04842682

Original source

ClinicalTrials.gov

Source last updated

Dec 17, 2024

Ingested at

May 23, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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NCT ID

NCT04842682

Title

A Phase I Multicenter Double-blind Placebo Controlled Dose Escalation Trial of an Adjuvanted Anti-CD40 mAb Fused to Env GP140 HIV Clade C ZM-96 (CD40.HIVRI.Env) Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Participants

Sponsor

ANRS, Emerging Infectious Diseases

Status

COMPLETED

Phase

Phase I

Condition raw

Healthy Adults

Condition normalized

Healthy Adults

Modality raw

Healthy Adults

Modality normalized

protein therapy

Target raw

HIV-1 Vaccine

Target normalized

HIV-1 Vaccine

Interventions

Solo 0.3 group, Solo 1 group, Solo 3 group, Combi 0.3 group, Combi 1 group, Combi 3 group, Late boost CD40 alone, Late boost CD40 adjuvanted

Public preview

Source record

The trial evaluates the safety and immunogenicity of the CD40.HIVRI.Env vaccine, both alone and in combination with the DNA-HIV-PT123 vaccine, in healthy volunteers. Conducted in France and Switzerland, it aims to establish a dose escalation strategy with a total enrollment of 72 participants. The study is sponsored by ANRS, Emerging Infectious Diseases.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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