Safety and Clinical Benefits of Adacel® and Adacel®-Polio Vaccination in Pregnancy: A Structured Literature Review.

Vaccination in pregnancy using a tetanus toxoid, reduced dose diphtheria toxoid, and reduced dose acellular pertussis (Tdap) vaccine is important for prevention of severe pertussis disease in young infants. The objectives of this systematic literature review were to search for original research studies evaluating the vaccine effectiveness, immunogenicity, and safety of Adacel®/Adacel-Polio® used during pregnancy to prevent pertussis disease in young infants. Medical databases used included EMBASE, BIOSIS Previews, and Chemical Abstracts, with search terms related to pregnancy, vaccines/immunization, safety, pertussis, effectiveness/efficacy, and immune response; other potentially eligible reports were included where applicable. Search results were restricted to literature published from 1 January 1995 to 26 July 2021. A total of 2021 articles and 4 other reports were identified for primary review. A total of 49 publications qualified for inclusion after primary and secondary reviews. Effectiveness studies of Adacel or Adacel-Polio given in pregnancy consistently showed high levels of protection from pertussis disease in the newborn (vaccine effectiveness: 91-93%). In immunogenicity studies, the response in pregnant women was consistent with that of non-pregnant women. Infants of mothers vaccinated with Adacel or Adacel-Polio in pregnancy had higher anti-pertussis antibody levels at birth and at 2 months of age compared to infants born to women vaccinated with comparator vaccines, placebo, or those not vaccinated during pregnancy. There was evidence of a slightly decreased response to primary pertussis vaccination in infants of mothers vaccinated with Adacel or Adacel-Polio, but this was not thought to be clinically significant. In safety studies, Adacel or Adacel-Polio vaccination was well tolerated by pregnant woman and not associated with pregnancy, postpartum, or neonatal complications. In conclusion, Adacel or Adacel-Polio vaccination in pregnancy is highly effective in protecting young infants from pertussis disease, with a favorable safety profile for both pregnant women and their infants.

Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis.

OBJECTIVE: To evaluate the effectiveness of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine containing five pertussis components (Tdap5; Adacel®, Sanofi) when given during pregnancy at preventing pertussis in infants less than 2 months of age. METHODS: The US Centers for Disease Control and Prevention (CDC), in collaboration with the Emerging Infections Program (EIP) Network, undertook a case-control study evaluating the effectiveness of Tdap vaccination in pregnancy against pertussis in infants less than 2 months of age based on data collected by the EIP Network from 2011 through 2014. The dataset from the CDC/EIP Network study was used to conduct this product-specific vaccine effectiveness analysis of Tdap5 vaccination in pregnancy to prevent disease in young infants. The main outcome of interest was vaccine effectiveness in infants whose pregnant parents were vaccinated with Tdap5 between 27 and 36 weeks' gestation, in accordance with the ideal timing for Tdap vaccination in pregnancy recommended by the US Advisory Committee on Immunization Practices. Odd ratios (ORs) and 95 % confidence intervals (CIs) were estimated using conditional logistic regression, and vaccine effectiveness was calculated as (1-OR) × 100 %. RESULTS: There were 160 infant pertussis cases and 302 matched controls included in this Tdap5-specific study. Tdap5 effectiveness in preventing pertussis in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation was 92.5 % (95 % CI, 38.5 %-99.1 %). Effectiveness of Tdap5 against pertussis-related hospitalization in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation could not be calculated due to lack of discordance among matched cases and controls. Vaccination of the parents after pregnancy or less than 14 days before delivery did not protect infants from pertussis. CONCLUSIONS: Tdap5 vaccination in pregnancy between 27 and 36 weeks' gestation is highly effective at protecting young infants from pertussis. STUDY REGISTRATION: ClinicalTrials.gov, NCT05040802.

Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women.

PURPOSE: Human papillomavirus (HPV) is the causative agent of cervical cancer. Black women are disproportionally diagnosed and have higher mortality from cervical cancer in the United States. Here we describe the prophylactic efficacy and safety of a quadrivalent HPV-6/11/16/18 vaccine in black women. METHODS: A total of 700 black women from Latin America, Europe, and North America (aged 16-24 years) received the vaccine or placebo in one of two studies. Analyses focused on the efficacy and safety of the vaccine. RESULTS: Baseline rates of Chlamydia trachomatis infection and history of past pregnancy were more than twice as high in black women compared with the non-black women who were enrolled in these trials. HPV-6/11/16 or 18 DNA was detected in 18% of black women versus 14.6% in non-black women at day 1. For black women, vaccine efficacy against disease caused by HPV-6/11/16/18 was 100% for cervical intraepithelial neoplasia (0 vs. 15 cases; 95% confidence interval, 64.5%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia and condylomata acuminata (0 vs. 17 cases; 95% confidence interval, 69.3%-100%). There were no serious vaccine-related adverse experiences. A similar proportion of pregnancies resulted in live births (75.8% vaccine; 72.7% placebo) and fetal loss (24.2% vaccine; 27.3% placebo). CONCLUSIONS: Prophylactic quadrivalent HPV-6/11/16/18 vaccination of young black women demonstrated high efficacy, safety, and tolerability. HPV vaccination has the potential to reduce cervical cancer-related health disparities both in the United States and around the world.

Menstrual irregularity from hormonal contraception: a cause of reproductive health concerns in minority adolescent young women.

CONTEXT: Adolescents are frequent users of hormonal contraception (HC), yet their adherence to these methods is often poor. Concerns about side effects, especially those affecting the menstrual system, are often given as reasons for contraceptive nonadherence or discontinuation. We sought to identify teens' concerns and misperceptions about the menstrual-related side effects of HC. METHODS: Open focus groups were conducted with both sexually active and virgin adolescent women aged 12-18 years who were recruited from the Philadelphia area. The adolescents did not have to be contraceptive users in order to participate. The question put to each group was, "What are the things you have heard about the birth control pill, Depo-Provera and Norplant?" Groups were audio-recorded, transcribed and analyzed using qualitative software. RESULTS: We conducted 13 female-only groups. Participants raised frequent concerns about menstrual-related side effects, believing that these side effects were evidence of possible negative effects of HC on their reproductive health. Four themes related to hormonal contraceptive-induced menstrual irregularity emerged from the groups. Theme 1: Menstruation is natural and should not be altered in any way. Theme 2: The menstrual period is necessary for cleansing of the body. Theme 3: "Spotting," intermenstrual bleeding and amenorrhea cause doubts about the method's effectiveness and worries about pregnancy. Theme 4: All menstrual irregularity, from intermenstrual bleeding to amenorrhea, causes worry about the effects on fertility and on physical health. CONCLUSIONS: Teens have concerns about the menstrual irregularity caused by HC. Providers understand that these side effects are minor and of little medical consequence. Yet, adolescent patients may be ascribing great significance to these effects and may be declining these methods because of fear and misperceptions.

Group B streptococcal vaginitis in postpubertal adolescent girls.

PURPOSE: The purpose of this study was to explore the clinical findings, diagnosis, and treatment of group B streptococcal (GBS) vulvovaginitis in a sample of adolescent girls and young women found to have this condition. METHODS: Descriptive retrospective analysis of charts of 13 adolescent girls and young women found to have GBS vulvovaginitis was performed. RESULTS: Of the girls and young women with GBS vulvovaginitis, almost all were found to have a purulent vaginal discharge (n = 12). Three had frank cervicitis and/or vaginitis on examination. Only 1 was diagnosed accurately with GBS vulvovaginitis at the time of the visit and 4 were treated with appropriate antibiotics at the time of the visit. CONCLUSIONS: GBS vulvovaginitis is a poorly diagnosed disease entity in the adolescent and young adult population. Further study is needed in the epidemiology of GBS vaginitis in postpubertal adolescent girls and women to improve the recognition, pathogenesis, and treatment of GBS vaginitis.

Fitz-Hugh-Curtis syndrome: a diagnosis to consider in women with right upper quadrant pain.

Fitz-Hugh-Curtis syndrome--inflammation of the liver capsule associated with genital tract infection--occurs in up to one fourth of patients with pelvic inflammatory disease (PID). Classically presenting as sharp, pleuritic right upper quadrant pain, usually but not always accompanied by signs of salpingitis, it can mimic many other common disorders such as cholecystitis and pyelonephritis.