Mangarule S, Palkar S, Mitra M, Ravi M D, Singh R, Moureau A, Jayanth M V, Patel D M, Ravinuthala S, Patnaik B N, Jordanov E, Noriega F
Sanofi Healthcare India Private Ltd (SHIPL), Hyderabad, India.
Bharati Vidyapeeth (Deemed to be) University Medical College, Pune, India.
Vaccine X. 2022 Jul 2;11:100190. doi: 10.1016/j.jvacx.2022.100190. eCollection 2022 Aug.
The combination of whole-cell pertussis (wP) antigens with established diphtheria (D), tetanus (T), hepatitis B (HB), type b (Hib), and inactivated poliomyelitis (IPV) antigens provides a high-quality DTwP-IPV-HB-PRP∼T vaccine. This study evaluated a DTwP-IPV-HB-PRP∼T booster coadministered with measles, mumps, and rubella (MMR) vaccine.
Phase II, open-label, randomized study. Healthy toddlers who had previously completed a DTwP-IPV-HB-PRP∼T or separate DTwP-HB-PRP∼T and IPV primary vaccination series received a DTwP-IPV-HB-PRP∼T booster vaccine at 12-24 months of age. All participants had also received 1 or 2 doses of measles-containing vaccine between primary vaccination and enrolment (N = 100 and N = 6, respectively). Those who had received 1 prior measles-containing vaccine received an MMR dose either concomitantly (N = 50) or 28 days after (N = 50) the DTwP-IPV-HB-PRP∼T booster. Immunogenicity was evaluated using validated assays and safety by parental reports.
Pre-booster vaccination, 100.0% participants showed antibody persistence after DTwP-IPV-HB-PRP∼T or DTwP-HB-PRP∼T and IPV for anti-T (≥0.01 IU/mL), anti-Hib (≥0.15 µg/mL), and anti-polio 3 (≥8 1/dil) and at least 95.8% of participants for anti-D (≥0.01 IU/mL), anti-HB (≥10 mIU/mL), and anti-polio 1 and 2 (≥8 1/dil). For the pertussis antigens, pre-booster antibody persistence (≥2 EU/mL) ranged from 88.6 to 88.7% (anti-PT), 91.4-98.6% (anti-FHA), 69.0-74.3% (anti-PRN), and 97.1-97.2% (anti-FIM). For the booster response, seroprotection based on either the primary series or measles-containing vaccination regimen was 100.0% for anti-D and anti-T (≥0.01 IU/mL and ≥0.10 IU/mL), anti-HB (≥10 mIU/mL and ≥100 mIU/mL), anti-Hib (≥0.15 µg/mL and ≥1 µg/mL) and anti-polio 1, 2, and 3 (≥8 1/dil), and for the pertussis antigens booster response ranged from 88.6 to 91.8% (anti-PT), 91.1-95.9% (anti-FHA), 88.6-93.9% (anti-PRN), and 95.9-98.6% (anti-FIM). There were no safety concerns in any group.
This study showed good antibody persistence of the DTwP-IPV-HB-PRP∼T vaccine and good immunogenicity and safety of a booster dose given with MMR in the second year of life.Clinical Trials Registry India Number: CTRI/2018/04/013375.
全细胞百日咳（wP）抗原与已有的白喉（D）、破伤风（T）、乙型肝炎（HB）、b型流感嗜血杆菌（Hib）和灭活脊髓灰质炎（IPV）抗原联合，可提供一种高质量的DTwP-IPV-HB-PRP∼T疫苗。本研究评估了与麻疹、腮腺炎和风疹（MMR）疫苗同时接种的DTwP-IPV-HB-PRP∼T加强疫苗。
II期、开放标签、随机研究。先前已完成DTwP-IPV-HB-PRP∼T或单独的DTwP-HB-PRP∼T和IPV基础免疫接种系列的健康幼儿在12至24月龄时接种DTwP-IPV-HB-PRP∼T加强疫苗。所有参与者在基础免疫接种和入组之间还接种了1或2剂含麻疹疫苗（分别为N = 100和N = 6）。那些先前接种过1剂含麻疹疫苗的参与者在接种DTwP-IPV-HB-PRP∼T加强疫苗的同时（N = 50）或之后28天（N = 50）接种1剂MMR。使用经过验证的检测方法评估免疫原性，并通过家长报告评估安全性。
加强免疫前接种疫苗后，100.0%的参与者在接种DTwP-IPV-HB-PRP∼T或DTwP-HB-PRP∼T和IPV后，抗-T（≥0.01 IU/mL）、抗-Hib（≥0.15 μg/mL）和抗脊髓灰质炎3型（≥8 1/dil）抗体持续存在，至少95.8%的参与者抗-D（≥0.01 IU/mL）、抗-HB（≥10 mIU/mL）以及抗脊髓灰质炎1型和2型（≥8 1/dil）抗体持续存在。对于百日咳抗原，加强免疫前抗体持续存在（≥2 EU/mL）的比例在88.6%至88.7%（抗-PT）、91.4% - 98.6%（抗-FHA）、69.0% - 74.3%（抗-PRN）和97.1% - 97.
