Immunogenicity of the pentavalent DTwP-HB-Hib vaccine (Shan-5) used in the Thai Expanded Program on Immunization compared to the hexavalent DTaP-HB-Hib-IPV and DTwP-HB-Hib (Quinvaxem) vaccines administered to infants at 2, 4, 6 months of age

Article

Author: Sarawanangkoor, Nasiri ; Thongmee, Thanunrat ; Posuwan, Nawarat ; Srimuan, Donchida ; Wanlapakorn, Nasamon ; Phanphanit, Kanchana ; Pruetarat, Napa ; Poovorawan, Yong ; Thatsanathorn, Thaksaporn

BACKGROUNDThe pentavalent DTwP-HB-Hib (Shan-5) vaccine was first introduced into the Thailand Expanded Program on Immunization (EPI) in 2019. The Shan-5 vaccine is administered to infants at 2, 4, and 6 months of age, after initial vaccination with monovalent hepatitis B (HepB) and Bacillus Calmette-Guérin (BCG) vaccines at birth. This study compared the immunogenicity of the HepB, diphtheria, tetanus, and Bordetella pertussis antigens incorporated in the EPI Shan-5 vaccine versus the optional pentavalent (DTwP-HB-Hib) Quinvaxem and hexavalent (DTaP-HB-Hib-IPV) Infanrix-hexa vaccine.METHODSThree-dose Shan-5-vaccinated children were prospectively enrolled at the Regional Health Promotion Centre 5, Ratchaburi province, Thailand, between May 2020 and May 2021. Blood sampling was performed at months 7 and 18. The levels of HepB surface antibody (anti-HBs), anti-diphtheria toxoid (DT) IgG, anti-tetanus toxoid (TT) IgG, and anti-pertussis toxin (PT) IgG were evaluated using commercially available enzyme-linked immunoassays.RESULTSAnti-HBs levels of ≥10 mIU/mL were achieved in 100 %, 99.2 %, and 99.2 % of infants in the Shan-5 EPI group, hexavalent group and Quinvaxem group one month after four dose immunization (at 0, 2, 4, 6 months of age), respectively. The geometric mean concentrations of the EPI Shan-5 and hexavalent groups were comparable but were higher than those of the Quinvaxem group. At one month after primary vaccination (month 7), infants in the Shan-5 EPI group had significantly higher levels of anti-DT IgG, anti-TT IgG, and anti-PT IgG than infants in the hexavalent and Quinvaxem groups.CONCLUSIONSThe immunogenicity of the HepB surface antigen in the EPI Shan-5 vaccine was similar to that achieved by the hexavalent vaccine, but was higher than that achieved by the Quinvaxem vaccine. The Shan-5 vaccine is highly immunogenic and generates robust antibody responses after primary immunization.

04 May 2022·Expert Review of VaccinesQ2 · MEDICINE

Safety of primary immunization with a DTwP-HBV/Hib vaccine in healthy infants: a prospective, open-label, interventional, phase IV clinical study

Q2 · MEDICINE

Article

Author: Capeding, Maria Rosario Z ; Modequillo, Margaret ; De Leon, Maria Nerissa ; Lopez, Anna Lena L. ; Gatchalian, Salvacion R. ; Flavier, Mervin Edcel E. ; Garcia Ibe, Maria E. ; Ong-Lim, Anna Lisa ; Yu, Delia C. ; Aseron, Mitzi

OBJECTIVEThis study aimed to assess the safety of a fully liquid DTwP-HBV/Hib pentavalent vaccine (Eupenta^TM) based on the occurrence of adverse events (AEs) following vaccination.METHODSThis was a prospective, open-label, single-arm, interventional phase IV study. A single intramuscular injection of the study vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, and an end-of-study follow-up visit was scheduled at 18 weeks.RESULTSIn all, 3000 subjects were enrolled and received at least one dose of the study vaccine. Of these, 2717 (90.6%) experienced at least one AE. Immediate reactions, solicited and unsolicited AEs were respectively identified in 224 (7.5%), 2,652 (88.4%), and 1,099 (36.6%) subjects. The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively. Most AEs were mildly or moderately severe. Forty-one (1.4%) subjects had at least one serious AE (SAE); of these, two (0.1%) had two SAEs each, considered related to the study vaccine. Six (0.2%) subjects died due to unsolicited AEs, none of which were considered related to the study vaccine. No AEs were reported at the end-of-study follow-up visit.CONCLUSIONSThe study vaccine had a safety profile similar to that reported in a previous clinical study, and did not result in an increased risk of AEs known to be associated with DTwP-based vaccines or previously unrecognized SAEs.

01 Oct 2020·Clinical TransplantationQ4 · MEDICINE

Immune responses to hepatitis B vaccination after hematopoietic stem cell transplantation in pediatric and young adult patients

Q4 · MEDICINE

Article

Author: Techasaensiri, Chonnamet ; Chaisavaneeyakorn, Sujittra ; Treepongkaruna, Suporn ; Boonsathorn, Sophida ; Apiwattanakul, Nopporn ; Chaichotjinda, Krittiya ; Anurathapan, Usanarat

AbstractBackgroundHematopoietic stem cell transplantation (HSCT) recipients require hepatitis B (HBV) revaccination. Hepatitis B surface antibody (anti‐HBs) seroconversion rates after revaccination range from 64% to 79% in these patients. The seroconversion rate and factors associated with non‐seroconversion have not been clearly elucidated in pediatric and young adult recipients after HSCT.ObjectivesTo evaluate anti‐HBs seroconversion rates in pediatric and young adult patients revaccinated after HSCT, and to identify factors associated with non‐seroconversion.MethodThe current study was prospective and cross‐sectional. Post‐HSCT recipients aged ≤25 years who had completed a course of three HBV revaccinations were recruited, and their anti‐HBs titers were assessed. Non‐seroconverted patients were administered a fourth vaccination. Those who subsequently remained seronegative were administered two additional vaccinations. Those who remained seronegative after all six vaccinations were defined as non‐responders.ResultsA total of 118 patients were enrolled. The HBV‐containing vaccines used included DTaP‐IPV‐HBV‐Hib, DTwP‐HBV‐Hib, and monovalent vaccines. The anti‐HBs seroconversion rate after three revaccinations was 82% (95% confidence interval [CI], 73.7‐89.2). One patient (0.8%) was classified as non‐responder. Factors associated with non‐seroconversion after three revaccinations included cytomegalovirus (CMV) reactivation (odds ratio [OR] 10.63, 95% CI 1.16‐97.00), anti‐HBs seronegativity before HSCT (OR 7.01, 95% CI 1.55‐31.78) and three DTwP‐HBV‐Hib revaccinations (OR 11.71, 95% CI 1.43‐96.26).ConclusionIn the current study the anti‐HBs seroconversion rate after three HBV revaccinations was excellent. CMV reactivation, anti‐HBs seronegativity before HSCT, and three DTwP‐HBV‐Hib revaccinations were associated with non‐seroconversion, but the non‐responder rate was low.

100 Deals associated with DTwP-HBV-HIB vaccine(Biological E. Ltd.)

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Indication	Country/Location	Organization	Date
Diphtheria	IN	Biological E. Ltd.	01 Jan 2011
Haemophilus Infections	IN	Biological E. Ltd.	01 Jan 2011
Hepatitis B	IN	Biological E. Ltd.	01 Jan 2011
Tetanus	IN	Biological E. Ltd.	01 Jan 2011
Whooping Cough	IN	Biological E. Ltd.	01 Jan 2011

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