Vaccines Today—November 7, 2025

LucidQuest

1 day ago

Get up to speed with this week’s Vaccine Research news, featuring clinical milestones, regulatory updates, and company highlights.

In Today’s Newsletter

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💊 Takeda QDENGA long-term Phase 3 data [1] [Global • 04 Nov 2025]

https://www.biospace.com/press-releases/new-phase-3-data-show-takedas-dengue-vaccine-delivers-7-years-of-sustained-protection-against-infection-and-hospitalization
Context: TIDES (DEN-301), double-blind, randomized, placebo-controlled Phase 3 in >20,000 children/adolescents (4–16 years) across 8 endemic countries; data presented at WSPID 29 Oct 2025.
Key point: Two-dose TAK-003 (QDENGA) provided sustained protection through seven years, with 61.2% VE vs virologically confirmed dengue at 4.5 years (95% CI 56.0–65.8), booster exploratory analysis increased efficacy to 74.3% after 2 years, and VE vs dengue-related hospitalization was 84.1% at 4.5 years and 90.6% after booster (CIs reported). No new safety signals observed.
Implication: Clinical topline/efficacy, “May influence prescriber choice and payer reviews pending full data.”

💉 CVD 1902 shows efficacy vs Salmonella Paratyphi A [2] [03 Nov 2025]

https://www.pharmacytimes.com/view/experimental-vaccine-shows-73-efficacy-against-salmonella-paratyphi-a
Context: Phase 2b randomized, double-blind, placebo-controlled controlled human infection model (ISRCTN15485902), n = 72, two oral doses then challenge; primary endpoint infection within 14 days.
Key point: Two doses of oral live attenuated CVD 1902 reduced challenge infection to 21% vs 75% in placebo, corresponding to 73% vaccine efficacy (95% CI 46–86) in intention-to-treat; similar safety profiles, no vaccine-related serious adverse events.
Implication: Clinical topline/efficacy, “May influence prescriber choice and payer reviews pending full data.”

🛡️ GC Biopharma BARYTHRAX Phase 2 published in Vaccine [3] [KR • 03 Nov 2025]

https://www.prnewswire.com/news-releases/gc-biopharmas-recombinant-anthrax-vaccine-barythrax-demonstrates-safety-and-immunogenicity-in-phase-2-data-published-in-vaccine-302602079.html
Context: Randomized, double-blind, placebo-controlled Phase 2 in 240 healthy adults across five Korean hospitals; results published in Vaccine.
Key point: Recombinant protein anthrax vaccine (BARYTHRAX) elicited toxin-neutralizing antibody levels exceeding a predefined protective threshold; adverse events were mostly mild and transient, no acute severe reactions or deaths.
Implication: Regulatory/generics, “Introduces competition that may affect pricing and formulary access,” and supports biodefense/pandemic preparedness.

🦟 Valneva VLA1601 Zika Phase 1 results [4] [FR • 04 Nov 2025]

https://valneva.com/wp-content/uploads/2025/11/2025_11_04_VLA1601_Phase1_Results_PR_EN_Final.pdf
Context: Randomized Phase 1 (VLA1601-102) in ~150 adults (18–49) in the US, two doses 4 weeks apart; low/medium/high antigen arms, and low dose with CpG1018 or 3M-052-AF adjuvants. Data to Day 57.
Key point: VLA1601 was generally safe and immunogenic across arms; double-adjuvant arms (low+alum+3M-052-AF and low+alum+CpG1018) produced significantly higher neutralizing GMTs and higher seroconversion (>93% vs 86%) and fold increases (>56-fold vs >7-fold) compared with single-adjuvant arm. No safety concerns identified.
Implication: Observational/RWE, “Could inform practice and payer discussions; interpretation depends on study design and confounding control,” and highlights vaccine design advances for mosquito-borne threats.

🌬️ CastleVax initiates Phase 2 for intranasal COVID-19 vaccine CVAX-01 [5] [05 Nov 2025]

https://www.biospace.com/press-releases/castlevax-announces-initiation-of-a-phase-2-study-evaluating-its-mucosally-delivered-next-generation-covid-19-vaccine-candidate
Context: Phase 2 dosing initiated, planned enrollment ~200 adults in the US, participants previously vaccinated, follow-up 6 months; comparator is an FDA-authorized injectable mRNA vaccine. Prior Phase 1 showed safety, tolerability, mucosal responses.
Key point: First participant dosed in a trial testing safety, tolerability and systemic/mucosal immunogenicity of intranasal NDV-vectored CVAX-01 versus an mRNA comparator; aims to evaluate mucosal immunity and potential to reduce transmission.
Implication: DTC/telehealth, “Could streamline initiation and adherence via remote prescribing and logistics,” and supports mucosal vaccine strategies to block infection/transmission.

🧬 Transgene TG4050 Phase I immunology at SITC 2025 [6] [FR/JP • 04 Nov 2025]

https://www.transgene.fr/wp-content/uploads/20251104_SITCAbstract_EN.pdf
Context: SITC 2025 poster and abstract present immunological data from TG4050 individualized neoantigen vaccine in operable head and neck squamous cell carcinoma (HNSCC), Phase I/II ongoing; Phase II immunogenicity readouts expected H2 2026.
Key point: TG4050 induced neoantigen-specific cytotoxic CD8+ T cells with effector and tissue-resident phenotypes persisting up to one year post-treatment, suggesting potential to eliminate tumor cells and reduce relapse risk.
Implication: Partnerships/BD, “Signals pipeline investment and modality expansion,” and supports individualized neoantigen vaccine approaches for relapse prevention.

Why it Matters

Long-duration dengue protection from QDENGA [1] could change public vaccination strategies in endemic countries, given high VE vs hospitalization.
A successful paratyphoid vaccine candidate (CVD 1902) [2] addresses a 2-million-case annual burden not covered by typhoid-only programs.
Recombinant anthrax vaccine BARYTHRAX [3] offers a scalable, protein-based biodefense option that may simplify stockpiling and manufacturing.
Valneva’s double-adjuvanted VLA1601 [4] shows how adjuvantation can markedly boost humoral responses in flavivirus vaccines.
Intranasal COVID boosters like CVAX-01 [5] target mucosal immunity, an important strategy to reduce transmission beyond systemic protection.
TG4050’s durable CD8+ responses [6] strengthen the rationale for individualized neoantigen therapeutics in adjuvant/relapse-prevention settings.

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FAQ

How durable is protection for Takeda’s QDENGA, and does a booster add value?

Two-dose QDENGA showed sustained protection through seven years with 61.2% VE vs virologically confirmed dengue at 4.5 years and high VE vs hospitalization; an exploratory booster at 4.5 years increased point estimates of efficacy (to 74.3% for VCD and to 90.6% vs hospitalization) with no new safety signals reported [1].

Is CVD 1902 ready for deployment in endemic settings?

A: CVD 1902 demonstrated ~73% efficacy in a controlled human infection phase 2b study, with favorable safety and immunogenicity; further field efficacy and larger trials in endemic populations would be needed before deployment [2].

What is novel about BARYTHRAX compared with existing anthrax vaccines?

A: BARYTHRAX is a recombinant protein-based anthrax vaccine that produced toxin-neutralizing antibody levels above a predefined protective threshold in Phase 2 and had a mostly mild safety profile; it may offer manufacturing and safety advantages over older approaches that used live or whole-cell components [3].

Do Valneva’s VLA1601 results change the Zika vaccine development outlook?

A: Phase 1 shows improved immunogenicity with double-adjuvant formulations and no new safety concerns, but Valneva states regulatory pathways and market opportunities remain uncertain, and further development will depend on funding [4].

What is the goal of CastleVax’s CVAX-01 intranasal program?

A: The Phase 2 study aims to assess whether intranasal NDV-vectored CVAX-01 can safely induce mucosal and systemic immunity that may reduce SARS-CoV-2 infection and transmission compared with an FDA-authorized mRNA vaccine [5].

What do TG4050 immunology data imply for cancer relapse prevention?

TG4050 induces persistent neoantigen-specific CD8+ T cells with effector and tissue-resident markers up to one year post-treatment, supporting its potential to reduce relapse risk in operable HNSCC; Phase II immunogenicity readouts are expected in H2 2026 [6].

Entities / Keywords

Takeda (QDENGA, TAK-003), dengue, TIDES (DEN-301), QDENGA, booster, vaccine efficacy, hospitalization VE; CVD 1902, Salmonella Paratyphi A, paratyphoid, controlled human infection model, ISRCTN15485902; GC Biopharma, BARYTHRAX (GC1109), recombinant anthrax vaccine, toxin-neutralizing antibodies, Vaccine journal; Valneva, VLA1601, Zika, adjuvants (CpG1018, 3M-052-AF), seroconversion, GMTs; CastleVax, CVAX-01, NDV-vectored intranasal vaccine, mucosal immunity, HexaPro; Transgene, TG4050, individualized neoantigen vaccine, CD8+ T cells, HNSCC, SITC 2025.