Safety and immunogenicity of a hexavalent DTwP-IPV-HB-PRP∼T vaccine versus separate DTwP-HB-PRP∼T and IPV vaccines in healthy infants in India

Mangarule, Somnath; Palkar, Sonali; Mitra, Monjori; Ravi, MD; Dubey, Anand Prakash; Moureau, Annick; Jayanth, MV; Patel, D.M; Jagga, S.R; Patnaik, Badri Narayan; Jordanov, Emilia; Noriega, Fernando

doi:10.1016/j.jvacx.2021.100137

Cited by 8 publications

(6 citation statements)

References 22 publications

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“…The seroprotection/seroresponse rates were comparable to other whole cell hexavalent combination vaccines and Pentavalent + IPV vaccines. 8 , 9 , 11 The GMCs of all antibodies exceeded the seroprotection/seroresponse thresholds by very large margins and are consistent with long-term protection reported in previous studies. 12 , 13 Similar to other clinical trials of wP-based DT combination vaccines 8 , 12 a diagnostic commercial ELISA kit was used to measure anti B. pertussis antibodies and the quantitative threshold of 24 U/ml was used to interpret the results, as per the kit literature.…”

Section: Discussionsupporting

confidence: 89%

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A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months

Sharma

Lalwani

Parekh

et al. 2022

Human Vaccines & Immunotherapeutics

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This first in human study was designed as an open label clinical trial to assess the safety and immunogenicity of SIIPL DTwP-HepB-IPV-Hib (Hexavalent) combination vaccine in healthy toddlers, aged 16–24 months. A total of 24 healthy toddlers were administered a 0.5 ml single dose of SIIPL DTwP-HepB-IPV-Hib vaccine intramuscularly, and followed for 28 days for safety outcomes viz. immediate, solicited, unsolicited and serious adverse events. Blood samples were collected immediately prior to and 28 days after vaccination to assess the immunogenicity. Twenty four completed the study in compliance with the study protocol. None of the participants experienced any immediate or any serious adverse event. In terms of the frequency and intensity, the adverse events were comparable to DTwP-based combination vaccines. The vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. One month post booster vaccination seroprotection for diphtheria, tetanus, Hepatitis B, Haemophilus influenzae type b and polio virus type 1 and 3 was 100%. The percentage sero-response for pertussis was 75%. Four-fold increase in antibody concentration for pertussis was achieved in 87.5% subjects. Indigenously developed DTwP-HepB-IPV-Hib vaccine by Serum Institute of India Pvt. Ltd. was found to be safe, well tolerated and showed a robust immune response in toddlers. It was concluded that this vaccine should be assessed in the next phases of clinical development in the target population. Clinical Trial Registration – CTRI/2018/10/015875.

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Section: Discussionsupporting

confidence: 89%

“…Also, as the ULOQ for polio neutralization was 128 (1/dil), an actual rise induced by the vaccine could not be assessed in this Phase I study, as reported in literature. 9 , 11 …”

Section: Discussionmentioning

confidence: 99%

A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months

Sharma

Lalwani

Parekh

et al. 2022

Human Vaccines & Immunotherapeutics

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“…The magnitude of the immune responses to DTwP-IPV-HB-PRP~T and DTwP-HB-PRP~T+bOPV+IPV was comparable to previous clinical studies conducted in India [3][4][5] and studies of similar pentavalent and hexavalent vaccines (containing aP rather than wP antigens) have not shown any reduction of the immune response when co-administered with rotavirus vaccines or PCV. [14][15][16][17] Furthermore, previous studies have shown the immune responses to rotavirus vaccine [15][16][17] and PCV 15,17,18 not to be affected by co-administration with DTaP-based vaccines, which is aligned with our findings.…”

Section: Discussionsupporting

confidence: 83%

“…Previous studies have shown good vaccine safety, strong immunogenicity and lot-to-lot consistency for the DTwP-IPV-HB-PRP~T vaccine following primary vaccination at 6–8, 10–12 and 10–14 weeks, and a booster at 12–24 months of age. 3–5 A full list of abbreviations used within this article can be found in Table, Supplemental Digital Content 1, http://links.lww.com/INF/F71.…”

mentioning

confidence: 99%

Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand

Sanchez,

Rungmaitree,

Kosalaraksa

et al. 2023

Pediatric Infectious Disease Journal

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Background: This study investigated the immunogenicity and safety of a fully liquid, hexavalent, diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) vaccine compared to licensed DTwP-HB-PRP~T, IPV, and bivalent oral poliovirus (bOPV) vaccines following co-administration with other pediatric vaccines [pneumococcal conjugate vaccine (PCV13) and rotavirus vaccine]. Methods: Phase III, randomized, open-label study in Thailand. Healthy infants received DTwP-IPV-HB-PRP~T at 2, 4 and 6 months of age (N = 228), or DTwP-HB-PRP~T and bOPV (2, 4 and 6 months of age) and IPV (4 months of age) (N = 231). All participants received PCV13 (2, 4 and 6 months of age) and rotavirus vaccine (2 and 4 months of age). Immunogenicity for all antigens was assessed using validated assays, and noninferiority post-third dose was evaluated for anti-D, anti-T, anti-pertussis [anti-pertussis toxin (anti-PT) and anti-fimbriae 2/3 (anti-FIM)], anti-polio 1, 2, 3, anti-HB, and anti-PRP~T. Safety was assessed using parental reports. Results: Noninferiority was demonstrated for each antigen, and overall noninferiority of DTwP-IPV-HB-PRP~T versus DTwP-HB-PRP~T+bOPV+IPV was concluded. Similarity in each group was observed for the GMC ratio for antirotavirus antibodies (20.9 and 17.3, respectively) and anti-PCV13 antibodies (range: 8.46–32.6 and 7.53–33.1, respectively). Two serious adverse events were related to DTwP-IPV-HB-PRP~T (febrile convulsion and acute febrile illness) and 1 was related to DTwP-HB-PRP~T+bOPV+IPV (febrile seizure), but overall there were no safety concerns with similar rates of participants experiencing solicited (99.1% and 98.3%) and unsolicited (19.3% and 19.5%) adverse events in each group. Conclusions: This study confirmed the suitability of DTwP-IPV-HB-PRP~T primary series vaccination in combination with rotavirus and PCV13 vaccines.

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“…In India, primary vaccination is recommended at 6, 10 and 14 weeks of age (D, T, pertussis, HB, Hib and poliomyelitis) and a booster at 16-18 months of age (D, T, pertussis, Hib and polio). 2 A fully liquid, hexavalent D, T, whole-cell pertussis (wP), inactivated poliovirus (IPV), HB and Hib [purified capsular polysaccharide with tetanus toxoid carrier protein (PRP~T)] vaccine (DTwP-IPV-HB-PRP~T: SHAN6) [3][4][5] combines well established D, T, wP, HB and Hib antigens from SHAN5 (DTwP-HB-PRP~T) and IPV from SHANIPV, both of which are widely used and prequalified by the World Health Organization. 6 Data have been reported previously from a Phase III clinical trial in approximately 1200 infants in India, which evaluated the immunogenicity and safety of a primary vaccination series of DTwP-IPV-HB-PRP~T at 6-8, 10-12 and 14-16 weeks of age and demonstrated noninferiority to licensed DTwP-HB-PRP~T+IPV vaccines.…”

mentioning

confidence: 99%

Antibody Persistence Following Administration of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T and IPV Vaccines and Safety and Immunogenicity of a Booster Dose of DTwP-IPV-HB-PRP~T Administered With an MMR Vaccine in Healthy Infants in India

Mangarule,

Siddaiah,

Kawade

et al. 2023

Pediatric Infectious Disease Journal

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Background: Antibody persistence of a whole-cell pertussis-containing hexavalent vaccine (DTwP-IPV-HB-PRP~T) and its co- or sequential administration with measles, mumps, rubella (MMR) vaccine were evaluated. Methods: Phase III, open-label, randomized, multicenter study in India. Healthy toddlers aged 12–24 months who had received DTwP-IPV-HB-PRP~T or separate DTwP-HB-PRP~T+IPV primary vaccination at 6–8, 10–12 and 14–16 weeks of age received a DTwP-IPV-HB-PRP~T booster concomitantly with MMR (N = 336) or 28 days before MMR (N = 340). Participants had received a first dose of measles vaccine. Immunogenicity assessment used validated assays and safety was by parental reports. All analyses were descriptive. Results: All participants had prebooster anti-T ≥0.01 IU/mL and anti-polio 1 and 3 ≥8 1/dil, and ≥96.5% had anti-D ≥0.01 IU/mL, anti-HBs ≥10 mIU/mL, anti-polio 2 ≥8 1/dil and anti-PRP ≥0.15 µg/mL; for pertussis, antibody persistence was similar in each group. Postbooster immunogenicity for DTwP-IPV-HB-PRP~T was similar for each antigen in each group: ≥99.5% of participants had anti-D ≥0.01 IU/mL, anti-T ≥0.01 IU/mL, anti-polio 1, 2 and 3 >8 1/dil, anti-HBs ≥10 mIU/mL and anti-PRP ≥1 µg/mL; for pertussis, vaccine response was similar in each group [72.0%–75.9% (anti-PT), 80.8%–81.4% (anti-FIM), 77.6%–79.5% (anti-PRN), 78.2%–80.8% (anti-FHA)]. There was no difference in MMR immunogenicity between groups, and no difference in DTwP-IPV-HB-PRP~T booster immunogenicity based on the primary series. There were no safety concerns. Conclusions: DTwP-IPV-HB-PRP~T antibody persistence was similar to licensed comparators. Booster immunogenicity was robust after DTwP-IPV-HB-PRP~T with or without MMR, and MMR immunogenicity was not affected by coadministration with DTwP-IPV-HB-PRP~T. Clinical Trials Registry India Number: CTRI/2020/04/024843.

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Safety and immunogenicity of a hexavalent DTwP-IPV-HB-PRP∼T vaccine versus separate DTwP-HB-PRP∼T and IPV vaccines in healthy infants in India

Cited by 8 publications

References 22 publications

A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months

A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months

Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand

Antibody Persistence Following Administration of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T and IPV Vaccines and Safety and Immunogenicity of a Booster Dose of DTwP-IPV-HB-PRP~T Administered With an MMR Vaccine in Healthy Infants in India

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