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

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.