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Immunogenicity and safety of concomitant vaccines given with 20-valent pneumococcal conjugate vaccine in healthy infants
Pneumococcal conjugate vaccines (PCVs) are generally administered in infant schedules with other vaccines. Here, we describe the safety and immunogenicity of routinely recommended pediatric vaccines given with 20-valent-PCV (PCV20).
Two phase 3, double-blind, randomized trials evaluated the safety, tolerability, and immunogenicity of PCV20 in infants with concomitant pediatric vaccines. The studies examined a 4-dose series (Study B7471011/NCT04382326; N = 1997) and a 3-dose series (Study B7471012/NCT04546425; N = 1207). Concomitant vaccinations included a combination vaccine (diphtheria, tetanus, acellular pertussis [DTaP] with hepatitis B and poliovirus antigens (DTaP-HBV-IPV) and Haemophilus influenzae type b vaccine [Hib]) in Study B7471011 or combined vaccine (DTaP, hepatitis B, poliovirus, and Hib antigens [DTaP-HBV-IPV/Hib]) in Study B7471012. Measles, mumps, rubella (MMR) and varicella vaccines were given concomitantly with the toddler dose in both studies. Immunogenicity objectives were to demonstrate noninferiority of immune responses to concomitant vaccine antigens for concomitant vaccines given with PCV20 to those given with 13-valent PCV (PCV13). Safety endpoints included systemic events and adverse events (AEs).
Noninferiority was met for the primary objectives of percentage of participants with prespecified antibody levels to the DTaP-HBV-IPV and Hib 1 month after the third infant dose (Study B7471011) and 1 month after the toddler dose of DTaP-HBV-IPV/Hib (Study B7471012) in the PCV20 group compared with the PCV13 group. Noninferiority was also met for the geometric mean antibody levels to MMR and varicella vaccines 1 month after the toddler dose in both studies. Systemic event frequencies were similar in the PCV20 and PCV13 groups in both studies, with severity mostly reported as mild or moderate. Frequencies of reported AEs were similar between the PCV20 and PCV13 groups.
Immune responses to routine pediatric vaccines given with PCV20 were noninferior to those when given with PCV13. PCV20 may be safely administered with other routine pediatric vaccines. (NCT04382326; NCT04546425).
•Two phase 3, double-blind, randomized trials evaluated PCV20 in infants.•The studies included concomitant administration of routine pediatric vaccines.•Immune responses to these concomitant pediatric vaccines were evaluated.•Responses to concomitant vaccines were noninferior with PCV20 to those with PCV13.•PCV20 may be safely administered with other routine pediatric vaccines.
Journal Article
Potential for Maternally Administered Vaccine for Infant Group B Streptococcus
Natural history studies have correlated serotype-specific anti-capsular polysaccharide (CPS) IgG in newborns with a reduced risk of group B streptococcal disease. A hexavalent CPS-cross-reactive material 197 glycoconjugate vaccine (GBS6) is being developed as a maternal vaccine to prevent invasive group B streptococcus in young infants.
In an ongoing phase 2, placebo-controlled trial involving pregnant women, we assessed the safety and immunogenicity of a single dose of various GBS6 formulations and analyzed maternally transferred anti-CPS antibodies. In a parallel seroepidemiologic study that was conducted in the same population, we assessed serotype-specific anti-CPS IgG concentrations that were associated with a reduced risk of invasive disease among newborns through 89 days of age to define putative protective thresholds.
Naturally acquired anti-CPS IgG concentrations were associated with a reduced risk of disease among infants in the seroepidemiologic study. IgG thresholds that were determined to be associated with 75 to 95% reductions in the risk of disease were 0.184 to 0.827 μg per milliliter. No GBS6-associated safety signals were observed among the mothers or infants. The incidence of adverse events and of serious adverse events were similar across the trial groups for both mothers and infants; more local reactions were observed in the groups that received GBS6 containing aluminum phosphate. Among the infants, the most common serious adverse events were minor congenital anomalies (umbilical hernia and congenital dermal melanocytosis). GBS6 induced maternal antibody responses to all serotypes, with maternal-to-infant antibody ratios of approximately 0.4 to 1.3, depending on the dose. The percentage of infants with anti-CPS IgG concentrations above 0.184 μg per milliliter varied according to serotype and formulation, with 57 to 97% of the infants having a seroresponse to the most immunogenic formulation.
GBS6 elicited anti-CPS antibodies against group B streptococcus in pregnant women that were transferred to infants at levels associated with a reduced risk of invasive group B streptococcal disease. (Funded by Pfizer and the Bill and Melinda Gates Foundation; C1091002 ClinicalTrials.gov number, NCT03765073.).
Journal Article
Frequently asked questions about vaccines and vaccinations
A guide to the history of and controversies sorrounding the practice of vaccination.
Book
Immunogenicity and safety of co-administration of sabin-strain-based inactivated poliovirus vaccine, diphtheria-tetanus-acellular pertussis vaccine, and live attenuated hepatitis A vaccine in 18-month-old children: A multicenter randomized controlled non-inferiority trial in China
Frequent healthcare visits increase children's risk of cross-infection. In both routine and emergency settings settings, co-administering vaccines or using combination vaccines can improve coverage, compliance, and timeliness. Vaccination is among the most cost-effective public health measures, with high coverage being critical for success, minimal immune interference, and improved programmatic efficiency.
This multicenter, randomized, open-label, non-inferiority phase IV trial extended a prior study (NCT04053010) to evaluate the immunogenicity and safety of co-administering sIPV, DTaP, and HepA-L in healthy Chinese children aged 18 months. Among 600 planned participants, 593 were enrolled and randomized (1:1:1:1) between November 2020 and January 2021: Group 1 (n = 148) received sIPV, DTaP, and HepA-L concomitantly; Groups 2/3/4 (n = 148/148/149) received sIPV, DTaP, or HepA-L separately as comparator controls. Immunogenicity non-inferiority was assessed via adjusted geometric mean ratios (co-ad group vs. sep-ad group per antigen) for poliovirus types I/II/III, DTaP components (DT, TT, PT, FHA), and HepA-L, with a prespecified margin of 0.67 for the 95 % CI lower bound. Antibody titers were assessed at baseline and 30 days post-vaccination: Poliovirus neutralizing antibodies (CPE method; reciprocal ND50 titer), DTaP antibodies (ELISA; IU/mL), HepA-L IgG (electrochemiluminescence immunoassay; IU/L). Safety was monitored for 6 months after vaccination to record any adverse events or serious adverse events.
Co-administration demonstrated non-inferior immunogenicity compared to separate administration for all antigens: polio types I (1271.21 vs. 1255.79), II (1915.91 vs. 2076.62), III (2306.41 vs. 2416.62); diphtheria (3.52 vs 3.31 IU/mL), pertussis toxoid (53.87 vs. 64.11 IU/mL); filamentous hemagglutinin (36.02 vs. 35.73 IU/mL), tetanus (9.23 vs 9.08 IU/mL), and hepatitis A (513.24 vs. 439.25 IU/L). Adverse event rates were comparable. Within 30 days post-vaccination, the overall adverse reaction (AR) incidence was higher in the co-administration group (11.49 %) than in Group 4 (4.70 %; P = 0.032) but was comparable to that in Group 2 (9.46 %) and Group 3 (6.08 %). Solicited local reactions occurred at similar rates across groups, with induration and redness being the most frequent. Similarly, fever was the predominant systemic reaction. Most ARs were Grade 1–2 in severity; Grade 3 events were rare (≤1.35 % across groups). No vaccine-related serious adverse events were reported.
Simultaneous sIPV+DTaP+HepA-L administration is immunologically non-inferior and exhibits an acceptable safety profile, supporting its potential integration to optimize immunization programs.
https://clinicaltrials.gov/study/NCT04636827?cond=NCT04636827&rank=1-ID:NCT04636827.
•First RCT study of sIPV+DTaP+HepA-L co-administration in China.•Non-inferior immunogenicity and acceptable safety of combined vaccination.•Reduce healthcare burdens in resource-limited settings.•Facilitates simultaneous childhood vaccination to enhance coverage.•Provides evidence for optimizing pediatric vaccine schedules.
Journal Article
Vaccination investigation : the history and science of vaccines
\"Learn more about the history and success rate of vaccines as well as their limitations, explore the challenges the medical community faces, and discover what vaccines are currently in development.\"--Provided by publisher.
Book
Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants
•DTaP-IPV-HB-PRP-T immunogenicity is similar when given concomitantly with a meningococcal C conjugate vaccine or alone.•The safety profile of DTaP-IPV-HB-PRP-T is similar when given concomitantly with a meningococcal C conjugate vaccine or alone.•These data support the concomitant use of DTa-IPV-HB-PRP-T vaccine with a meningococcal C conjugate vaccine.
DTaP-IPV-HB-PRP-T or hexavalent vaccines are indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The present study evaluates the safety and immunogenicity of a ready-to-use hexavalent vaccine when co-administered with a meningococcal serogroup C conjugate (MenC) vaccine in infants.
This was a phase III, open-label, randomised, multicentre study conducted in Finland. Healthy infants, aged 46–74days (n=350), were randomised in a ratio of 1:1 to receive DTaP-IPV-HB-PRP-T vaccine at two, three and four months, either with a MenC vaccine co-administered at two and four months (Group 1; n=175) or without MenC vaccine (Group 2; n=175). All infants also received routine rotavirus and 13-valent pneumococcal conjugate vaccines.
The proportion of participants with an anti-HBs concentration ⩾10mIU/mL assessed one month after the third dose of DTaP-IPV-HB-PRP-T vaccine was 97.5% [95%CI: 93.1–99.3] in the coadministration group and 96.1% [95%CI: 91.8–98.6] in the group without MenC vaccine. The proportion of participants with an anti-MenC SBA titre ⩾8 assessed one month after the second dose of MenC vaccine was 100% in the coadministration group. Both primary objectives were achieved.
Secondary immunogenicity and safety analyses showed that co-administration of DTaP-IPV-HB-PRP-T and MenC vaccines did not impact the immune response to the antigens of each of the two vaccines. All vaccines were well tolerated and the safety profile of DTaP-IPV-HB-PRP-T vaccine was similar in both groups.
ClinicalTrials.gov identifier: NCT01839175; EudraCT number: 2012-005547-24.
Journal Article
Covid-19 : what you need to know about the coronavirus and the race for the vaccine
\"This book charts the trajectory of the COVID-19 virus, from its emergence in China at the end of 2019 to its rapid worldwide spread. Based on the latest scientific discoveries, Dr. Mosley gives you a detailed understanding of the secrets of this coronavirus, how it spreads, how it infects your body and how your immune system tries to fight back. Armed with the facts you'll be in a much better position to protect yourself and your family when the world begins to reopen. Dr. Mosley also follows the work of leading doctors and virus researchers as they battle to find treatments and a safe and effective vaccine (ultimately, the only way to defeat the virus). Eating well, sleeping soundly, exercising and managing your stress are all critical for keeping your brain, body and immune system in the best possible shape over the coming months. These are areas where Dr. Mosley is well known for his science-based and practical approach.\" -- Provided by publisher.
Book
A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers
Combination vaccines are effective in simplifying complex vaccination schedules involving multiple vaccines. A fully liquid hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)- hepatitis B (HepB)-inactivated poliovirus (IPV)-Haemophilus influenzae b (Hib) vaccine (HEXASIIL®), manufactured by Serum Institute of India Pvt. Ltd. was tested for safety and immunogenicity following booster vaccination.
This was a phase-II/III, open label, multicentric, controlled trial in toddlers (phase II) and infants (phase III) in India. This manuscript presents results of phase II. Healthy toddlers aged 12–24 months were randomized (1:1) to receive a 0.5 ml booster dose of HEXASIIL® or comparator Pentavac SD + Poliovac, intramuscularly and followed for 28 days for safety assessment. Blood samples were collected pre-vaccination and 28 days post-vaccination to assess immunogenicity. Descriptive summary statistics were provided for safety and immunogenecity analyses.
A total of 223 subjects were randomized. One subject droped out prior to dosing, due to consent withdrawal. Thus, 222 subjects received study vaccine (110 HEXASIIL® and 112 comparator). Frequency of solicited adverse events was comparable between HEXASIIL® and comparator (85.5 % vs 90.2 %). Most local and systemic solicited AEs were mild to moderate in severity. All events resolved completely without any sequelae and none led to subject discontinuation. No vaccine related serious AE was reported. Post vaccination, seroprotection rates against tetanus, Hib and polio type 1 and 3 were 100 % in both the groups. Seroprotection rates for diphtheria (99.1 % vs 100 %) and polio type 2 (98.2 % vs 100 %) were observed in HEXASIIL® and comparator group, respectively. For Hepatitis B, seroprotection was >99 % in both groups. Seroconversion observed for Bordetella Pertussis (94.5 % vs 95.4 %) and Pertussis Toxin (77.1 % vs 87.2 %) in HEXASIIL® and comparator group, respectively.
HEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants.
Clinical Trial Registration – CTRI/2019/11/022052.
•Combination vaccines simplify vaccination schedules and improve compliance.•HEXASIIL® vaccine was compared to licensed DTwP-HepB-Hib + IPV vaccines.•HEXASIIL® had good safety and immunogenicity profile.•The data supported further evaluation of HEXASIIL® in infants.
Journal Article