Enhancing immunogenicity: Evaluating the polio antigen immune response in hexavalent vaccine formulations

Q: What are the key findings of this study?

Candidate sIPV hexavalent vaccines elicited significant poliovirus-specific IgG responses across serotypes 1, 2, and 3 at week 8 (p≤0.010) in rats, without a consistent dose-response pattern.

Q: What is the clinical evidence from this study?

Population: Poliomyelitis immunization (Preclinical animal model) (n=40). Intervention: Candidate hexavalent vaccine (DTwP-HepB-Hib-sIPV) vs. Pentavalent Bio Farma vaccine with sIPV (active comparator) or aluminum phosphate adjuvant control. Primary outcome: Longitudinal poliovirus-specific IgG antibody titers against sIPV serotypes 1, 2, and 3 at weeks 0, 4, 8, and 12 (p=<0.001).

Q: What does this research mean for the field?

Candidate hexavalent vaccine formulations containing Sabin-strain inactivated poliovirus elicit significant serotype-specific IgG responses across poliovirus serotypes 1, 2, and 3 in rats without a consistent dose-response pattern. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate poliovirus-specific IgG antibody responses elicited by candidate hexavalent vaccine formulations containing various doses of Sabin strain-derived inactivated poliovirus vaccine.

Tiza Wuri Mawaddah; Elisa D. Pratiwi; Arif Rahman Sadjuri; Dimas Tri Nugroho; Arip Hidayat; Acep Riza Wijayadikusumah; Astria Novitasari Nidom; Zakiyyan I. Ayyuba; Kadek Rachmawati; Suwarno Suwarno; Jola Rahmahani; Setyarina Indrasari; Reviany V. Nidom; Chairul Anwar Nidom

doi:10.52225/narra.v6i3.3140

October 15, 2026Narra JOpen Access

Enhancing immunogenicity: Evaluating the polio antigen immune response in hexavalent vaccine formulations

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Key result

Candidate sIPV hexavalent vaccines induce robust poliovirus IgG responses across all three serotypes in preclinical models.

P<0.001
n=40

Why the study?

Hexavalent vaccines combine antigens against six childhood diseases in a single formulation, requiring evaluation of the immunogenicity of each component, including candidate formulations with varying doses of Sabin strain-derived inactivated poliovirus vaccine (sIPV).

Does a candidate hexavalent vaccine containing low, medium, or high doses of Sabin strain-derived inactivated poliovirus vaccine (sIPV) improve poliovirus-specific IgG antibody responses compared to pentavalent vaccine plus sIPV or adjuvant control in Wistar rats?

Key Points

To evaluate poliovirus-specific IgG antibody responses elicited by candidate hexavalent vaccine formulations containing various doses of Sabin strain-derived inactivated poliovirus vaccine.
Conducted a preclinical study in 40 Wistar rats divided into five groups (four males and four females per group): hexavalent vaccine with low-, medium-, or high-dose sIPV; pentavalent vaccine combined with sIPV; or adjuvant control.
Administered primary immunization at week 0 and booster doses at weeks 4 and 8, assessing serotype-specific IgG titers at weeks 0, 4, 8, and 12 via indirect enzyme-linked immunosorbent assay and repeated-measures ANOVA.
Significant between-group differences in IgG titers emerged at weeks 8 and 12 for serotype 1 (p<0.001 and p=0.010), serotype 2 (both p<0.001), and serotype 3 (both p=0.010).
Antibody titers peaked markedly across all vaccinated groups at week 8 before declining at week 12, though no consistent dose–response pattern appeared across serotypes, time points, or sexes.
All experimental animals survived and consistently gained body weight throughout the 12-week observation period.

Structured PICO

Does a candidate hexavalent vaccine containing low, medium, or high doses of Sabin strain-derived inactivated poliovirus vaccine (sIPV) improve poliovirus-specific IgG antibody responses compared to pentavalent vaccine plus sIPV or adjuvant control in Wistar rats?

P

Population

40 clinically healthy specific pathogen-free Wistar rats (50% female, aged 6-8 weeks) immunized and followed for 12 weeks in a preclinical vaccine evaluation.

I

Intervention

Candidate hexavalent vaccine (DTwP–HepB–Hib–sIPV containing diphtheria ≥60 IU, tetanus ≥40 IU, whole-cell pertussis ≥4 IU, hepatitis B surface antigen ≥10 µg, Hib ≥10 µg, and 0.33 mg aluminum phosphate adjuvant) with low-dose (10, 30, and 30 DU), medium-dose (12, 38, and 38 DU), or high-dose (15, 45, and 45 DU) Sabin strain-derived inactivated poliovirus vaccine (sIPV) serotypes 1, 2, and 3, administered intramuscularly (0.5 mL total volume divided equally between two thigh muscles) at week 0 (primary) and weeks 4 and 8 (boosters).

C

Comparator

Pentavalent Bio Farma vaccine combined with sIPV (active comparator, Group 4) or aluminum phosphate adjuvant formulation without vaccine antigens (placebo/control, Group 5), administered intramuscularly at weeks 0, 4, and 8.

O

Outcome

Longitudinal poliovirus-specific immunoglobulin G (IgG) antibody titers against sIPV serotypes 1, 2, and 3 measured at weeks 0, 4, 8, and 12 using indirect enzyme-linked immunosorbent assay (ELISA).surrogate

Main Result

p-value: p=<0.001

Candidate hexavalent vaccine formulations containing sIPV elicited robust poliovirus-specific binding-IgG responses and were well-tolerated in Wistar rats, supporting further preclinical development with functional neutralization assays.

Limitations

Preclinical animal study in Wistar rats with a short 12-week follow-up
Indirect ELISA measured total antigen-binding IgG rather than functional poliovirus-neutralizing antibodies
Considerable background reactivity and antibody measurements were recorded in the adjuvant-control group
Post hoc pairwise comparisons among experimental groups were not reported
Immunological interference or synergy could not be established because sIPV alone was not included and responses to other vaccine antigens were not measured
Memory B cells, antibody avidity, IgG subclasses, and cellular immune responses were not evaluated
Safety assessments were descriptive and lacked hematological, biochemical, or histopathological evaluations
Memory B-cell formation was not directly evaluated, so observed antibody kinetics cannot be interpreted as long-term immunological memory.
Direct comparisons of absolute titers across serotypes are limited because serotype-specific coating-antigen concentrations differed in the indirect ELISA.
Considerable antibody measurements were recorded in the adjuvant-control group at weeks 8 and 12, likely reflecting nonspecific binding, cross-reactivity, background ELISA reactivity, or limitations in antibody-titer calculation.
Post hoc pairwise comparisons were not reported, preventing conclusions on whether a specific formulation produced significantly higher titers than another.
Functional serotype-specific neutralization assays were not performed in this stage.

Implication

Supports continued preclinical development of sIPV hexavalent vaccines; leaves open translation to human immunogenicity.

Abstract

Hexavalent vaccines simplify childhood immunization by combining antigens against six diseases in a single formulation; however, the immunogenicity of each component must be evaluated. This study assessed poliovirus-specific immunoglobulin G (IgG) responses elicited by candidate hexavalent vaccines containing different doses of Sabin strain-derived inactivated poliovirus vaccine (sIPV). A preclinical study was conducted using 40 Wistar rats allocated to five groups: hexavalent vaccine containing low-, medium-, or high-dose sIPV; pentavalent vaccine combined with sIPV; or adjuvant control. Each group comprised four male and four female rats. The animals received primary immunization at week 0 and booster doses at weeks 4 and 8. Serotype-specific IgG titers were measured at weeks 0, 4, 8, and 12 using indirect enzyme-linked immunosorbent assay. Antibody responses were analyzed using repeated-measures analysis of variance. Titers against poliovirus serotypes 1, 2, and 3 were negligible at baseline and remained low at week 4. Marked responses were observed in all vaccinated groups at week 8, followed by lower titers at week 12. Significant between-group differences were detected at weeks 8 and 12 for serotype 1 (p<0.001 and p=0.010), serotype 2 (both p<0.001), and serotype 3 (both p=0.010). However, no consistent dose–response pattern was observed across serotypes, time points, or sexes. All animals survived and gained body weight during follow-up. The candidate hexavalent formulations elicited marked poliovirus-specific binding-IgG responses, supporting further preclinical evaluation using validated serological and serotype-specific neutralization assays.

Discussion

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Cite This Study

Mawaddah et al. (2026) studied Poliomyelitis immunization (Preclinical animal model) (n=40). Candidate hexavalent vaccine (DTwP-HepB-Hib-sIPV) vs. Pentavalent Bio Farma vaccine with sIPV (active comparator) or aluminum phosphate adjuvant control was evaluated on Longitudinal poliovirus-specific IgG antibody titers against sIPV serotypes 1, 2, and 3 at weeks 0, 4, 8, and 12 (p=<0.001). Candidate sIPV hexavalent vaccines elicited significant poliovirus-specific IgG responses across serotypes 1, 2, and 3 at week 8 (p≤0.010) in rats, without a consistent dose-response pattern.

synapsesocial.com/papers/6ae28e56cbadf70daf6c4220 https://doi.org/10.52225/narra.v6i3.3140

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Enhancing immunogenicity: Evaluating the polio antigen immune response in hexavalent vaccine formulations

Key Points

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Enhancing immunogenicity: Evaluating the polio antigen immune response in hexavalent vaccine formulations

Key Points

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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