Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Aug 30:62:127558.
doi: 10.1016/j.vaccine.2025.127558. Epub 2025 Jul 31.

Immunogenicity and safety of the live-attenuated tetravalent dengue vaccine (TAK-003) co-administered with recombinant 9-valent human papillomavirus vaccine

Tarek El Hindi  1 , Suvaporn Anugulruengkitt  2 , Keswadee Lapphra  3 , Kriengsak Limkittikul  4 , Auchara Tangsathapornpong  5 , Claudia Galindo-Tsoukas  6 , Michael Hellwig  7 , Nicholas Roubinis  7 , Ron Schuring  7 , Shibadas Biswal  6 , Nicolas Folschweiller  7
Affiliations
Free article
Clinical Trial

Immunogenicity and safety of the live-attenuated tetravalent dengue vaccine (TAK-003) co-administered with recombinant 9-valent human papillomavirus vaccine

Tarek El Hindi et al. Vaccine. .
Free article

Erratum in

Abstract

Background: The tetravalent dengue vaccine TAK-003 and the 9-valent human papillomavirus (9vHPV) vaccine regimens are potentially compatible, with overlapping target age groups, facilitating inclusion of TAK-003 into established immunization programs.

Methods: This phase 3, open-label, randomized, multicenter trial was conducted in Thailand to investigate the immunogenicity and safety of co-administration of TAK-003 with 9vHPV in healthy participants aged ≥9 to <15 years. Participants were randomized 1:1 to either Group 1 (9vHPV + TAK-003 Month [M]0, TAK-003 M3, 9vHPV M6) or Group 2 (9vHPV M0 and M6) and followed up for 6 months after last vaccination. The primary objective was non-inferiority (NI) (upper bound of the 95 % confidence intervals for the HPV total immunoglobulin G (IgG) level ratio < 1.5) of the immune response to 9vHPV co-administered with TAK-003 versus 9vHPV alone at M7 (1 month after the last 9vHPV dose). Safety was assessed for all participants who received at least one vaccine dose.

Results: The trial was completed by 606/614 (98.7 %) participants and 477/614 (77.7 %) participants were included in the per-protocol set (PPS) (Group 1 = 242; Group 2 = 235). Total HPV IgG levels for HPV types ranged from 504 to 7778 mMU/mL in Group 1 and 561-7823 mMU/mL in Group 2 at M7 and NI was demonstrated for all HPV types. Seropositivity rates at M4 were ≥ 99.6 % for all dengue serotypes. No new safety risks were identified from this trial.

Conclusions: These findings support the co-administration of the TAK-003 and 9vHPV vaccines.

Clinicaltrials: gov registration number: NCT04313244.

Keywords: Co-administration; Dengue; Recombinant 9-valent human papillomavirus vaccine; TAK-003; Vaccination.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Tarek El Hindi reports financial support was provided by Takeda Vaccines, Inc. Claudia Galindo-Tsoukas reports financial support was provided by Takeda Vaccines, Inc. Michael Hellwig reports financial support was provided by Takeda Vaccines, Inc. Nicholas Roubinis reports financial support was provided by Takeda Vaccines, Inc. Ron Schuring reports financial support was provided by Takeda Vaccines, Inc. Shibadas Biswal reports financial support was provided by Takeda Vaccines, Inc. Nicolas Folschweiller reports financial support was provided by Takeda Vaccines, Inc. Suvaporn Anugulruengkitt reports financial support was provided by Takeda Vaccines, Inc. Tarek El Hindi reports a relationship with Takeda Vaccines, Inc. that includes: employment and equity or stocks. Claudia Galindo-Tsoukas reports a relationship with Takeda Vaccines, Inc. that includes: employment and equity or stocks. Michael Hellwig reports a relationship with Takeda Vaccines, Inc. that includes: employment and equity or stocks. Nicholas Roubinis reports a relationship with Takeda Vaccines, Inc. that includes: employment and equity or stocks. Ron Schuring reports a relationship with Takeda Vaccines, Inc. that includes: employment and equity or stocks. Shibadas Biswal reports a relationship with Takeda Vaccines, Inc. that includes: employment and equity or stocks. Nicolas Folschweiller reports a relationship with Takeda Vaccines, Inc. that includes: employment and equity or stocks. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Publication types

MeSH terms

Associated data