Center of Excellence in Respiratory Pathogens (CERP), Hospices Civils de Lyon and Centre International de Recherche en Infectiologie (CIRI), Équipe Santé publique, épidémiologie et écologie évolutive des maladies infectieuses (PHE3ID), Inserm U1111, CNRS UMR5308, ENS de Lyon, Université Claude Bernard Lyon 1, Lyon, France.
South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences.
AIDS. 2023 Dec 1;37(15):2305-2310. doi: 10.1097/QAD.0000000000003731. Epub 2023 Oct 3.
Vaccination during pregnancy with tetanus-diphtheria-acellular pertussis (Tdap) vaccine is recommended to protect the young infants against pertussis. There is a paucity of data on immune responses to Tdap in pregnant women with HIV (PWWH), and its impact on the protection of their infants has not been described.
In an open label phase IV clinical trial in South Africa, we evaluated the immunogenicity and safety of Tdap in PWWH compared with HIV-uninfected women. Antigen-specific immunoglobulin G (IgG) to pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae, diphtheria and tetanus were measured by electrochemiluminescence-based multiplex assay.
Overall, 91 PWWH and 136 HIV-uninfected pregnant women were enrolled. All PWWH were on antiretroviral treatment and 94.5% had HIV viral loads <40 copies per millilitre. Antibody levels prevaccination were lower among PWWH compared with HIV-uninfected women for all antigens. At 1 month postvaccination PWWH compared with HIV-uninfected women had lower fold-increase and antibody concentrations for all epitopes. Also, a lower proportion of PWWH achieved ≥4-fold increase from pre to postvaccination for pertussis toxoid and pertactin, or diphtheria IgG levels ≥0.1 IU/ml and ≥1 IU/ml postvaccination. Adverse events postvaccination were similar in PWWH and HIV-uninfected.
Tdap vaccination was safe and immunogenic. PWHW had, however, attenuated humoral immune responses, which could affect the effectiveness of protecting their infants against pertussis compared with those born to women without HIV.ClinicalTrials.gov identifier: NCT05264662.
接种破伤风、白喉和无细胞百日咳（Tdap）疫苗可预防婴幼儿百日咳。目前，关于人类免疫缺陷病毒（HIV）感染孕妇（PWWH）接种 Tdap 疫苗后的免疫反应数据有限，其对保护婴儿的影响也尚未描述。
在南非开展的一项 Tdap 疫苗的开放性、四期临床试验中，我们评估了 PWWH 与未感染 HIV 的孕妇相比，接种 Tdap 疫苗的免疫原性和安全性。通过基于电化学发光的多重分析，测量针对百日咳类毒素、丝状血凝素、丝状血细胞凝集素、菌毛、白喉和破伤风的抗原特异性免疫球蛋白 G（IgG）。
总体而言，纳入了 91 名 PWWH 和 136 名未感染 HIV 的孕妇。所有 PWWH 均接受抗逆转录病毒治疗，94.5%的 HIV 病毒载量<40 拷贝/毫升。与未感染 HIV 的孕妇相比，所有抗原的抗体水平在 PWWH 中都较低。在接种疫苗后 1 个月，与未感染 HIV 的孕妇相比，PWWH 的所有表位的抗体浓度和 fold-increase 都较低。此外，与接种疫苗前相比，较低比例的 PWWH 在接种疫苗后达到了百日咳类毒素和丝状血细胞凝集素的 4 倍以上增加，或白喉 IgG 水平≥0.1IU/ml 和≥1IU/ml。接种疫苗后的不良事件在 PWWH 和未感染 HIV 的孕妇中相似。
Tdap 疫苗接种是安全且具有免疫原性的。然而，PWHW 的体液免疫反应较弱，这可能会影响保护其婴儿免受百日咳的有效性，与那些未感染 HIV 的母亲所生的婴儿相比。
NCT05264662。
