What question did this study set out to answer?

To evaluate the safety and immunogenicity of a prime-boost HIV vaccine regimen utilizing DNA priming and a replicating vaccinia virus Tiantan (rTV) vector boost encoding HIV-1 CN54 env, gag, and pol genes.

July 1, 2025Signal Transduction and Targeted TherapyOpen Access

Safety and immunogenicity of an HIV vaccine trial with DNA prime and replicating vaccinia boost

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To evaluate the safety and immunogenicity of a prime-boost HIV vaccine regimen utilizing DNA priming and a replicating vaccinia virus Tiantan (rTV) vector boost encoding HIV-1 CN54 env, gag, and pol genes.
Phase Ia tested safety in 12 healthy adults receiving high (n=6) or low (n=6) doses of recombinant vaccinia virus Tiantan vaccine (rTV).
Phase Ib assigned 36 healthy adults to DNA alone (n=6), low-dose DNA/rTV (n=12), high-dose DNA/rTV (n=12), or placebo (n=6), with intramuscular DNA administered at weeks 0, 4, and 8, followed by bifurcated-needle rTV at week 12.
The vaccine regimens were safe and well-tolerated, with mostly mild-to-moderate adverse events comprising local site redness, papules, and axillary lymphadenopathy.
The DNA prime-rTV boost elicited anti-gp120 IgG antibodies and polyfunctional CD4+ T cells, with no significant differences observed between high- and low-dose DNA groups.
Smallpox-naive individuals generated higher T-cell and anti-gp120 antibody responses than smallpox-experienced individuals, who demonstrated smaller cutaneous lesions and faster healing times.

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Implication

Phase I trial demonstrates safety and robust immunogenicity of a DNA prime-replicating vaccinia boost HIV regimen in healthy adults, supporting advancement to later-stage trials.

Cite This Study

Liu et al. (2025) studied this question.

synapsesocial.com/papers/6a80ab28fcb29c286731f27e https://doi.org/10.1038/s41392-025-02259-y

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Implication

Phase I trial demonstrates safety and robust immunogenicity of a DNA prime-replicating vaccinia boost HIV regimen in healthy adults, supporting advancement to later-stage trials.

Safety and immunogenicity of an HIV vaccine trial with DNA prime and replicating vaccinia boost

Key Points

Discussion

Implication

Cite This Study

Safety and immunogenicity of an HIV vaccine trial with DNA prime and replicating vaccinia boost

Key Points

Discussion

Implication

Cite This Study

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