一项了解 HIV 感染孕妇及其婴儿疫苗 RSVpreF 的研究 (MORISOT)
2026年6月30日 更新者：Pfizer
一项 3 期、随机、双盲、安慰剂对照试验，旨在评估呼吸道合胞病毒 (RSV) 预融合 F 亚单位疫苗在感染 HIV 的孕妇及其婴儿中的安全性、耐受性和免疫原性
该研究的目的是了解 RSVpreF 疫苗的安全性和免疫活性。 将对感染艾滋病毒的母亲所生的婴儿进行研究。 这些婴儿因 RSV 感染而生病或死亡的机会可能更高。 呼吸道合胞病毒 (RSV) 是一种常见的病毒（细菌）类型，可导致严重疾病（气道疾病），需要医疗帮助。 疫苗可以帮助您的身体产生有助于对抗疾病的抗体。 抗体是您的身体用来抵抗感染的物质。 抗体可以通过母亲的胎盘传递给婴儿。
该研究将着眼于母亲及其婴儿的安全性、耐受性和免疫活性。
这项研究正在寻找符合以下条件的孕妇：
- 年龄小于或等于 49 岁且患有 HIV（人类免疫缺陷病毒 -
- 怀孕期间接受标准医疗护理
- 没有梅毒（细菌性传播疾病）、乙型肝炎病毒（（HBV）肝脏感染）、结核病（（TB）细菌性肺部感染）。
- 已接受稳定（抗逆转录病毒）HIV 治疗超过或等于 90 天。
- 同意参加所有研究访视、手术和抽血。
参与者将收到：
- RSVpreF 疫苗
- 安慰剂。 安慰剂没有任何药物，但看起来就像研究疫苗一样。
怀孕参与者将参与以下研究：
- 在当前怀孕期间同意，并且
- 产后 6 个月（总共约 10 个月）。 怀孕参与者将在本研究中计划至少进行 5 次访视。 婴儿参与者：所有登记母亲所生的符合条件的婴儿将从出生起接受长达 6 个月的随访。 婴儿参与者将进行至少 3 次研究访问，其中一些现场访问允许通过家访或通过电话进行。
研究概览
研究类型
介入性
注册 (实际的)
681
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Eastern Cape
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East London、Eastern Cape、南非、5241
- Synergy Biomed Research Institute
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Free State
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Bloemfontein、Free State、南非、9301
- Josha Research
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Gauteng
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Benoni、Gauteng、南非、1500
- Worthwhile Clinical Trials
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Boksburg、Gauteng、南非、1459
- REIMED Reiger Park
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Johannesburg、Gauteng、南非、2001
- Wits RHI
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Johannesburg、Gauteng、南非、2013
- University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
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Johannesburg、Gauteng、南非、2093
- Wits VIDA Nkanyezi Research Unit
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Pretoria、Gauteng、南非、0184
- Botho ke Bontle Health Services
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Pretoria、Gauteng、南非、0152
- Setshaba Research Centre
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KwaZulu-Natal
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Ladysmith、KwaZulu-Natal、南非、3370
- Qhakaza Mbokodo Research Clinic
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Limpopo
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Polokwane、Limpopo、南非、0699
- Gole Biomed Research Centre
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Western Cape
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Cape Town、Western Cape、南非、7700
- MRC Unit on Child And Adolescent Health
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Cape Town、Western Cape、南非、7750
- Gugulethu Green Clinic
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Worcester、Western Cape、南非、6850
- FAMCRU - Worcester
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
主要纳入标准 - 母亲参与者
- 计划接种疫苗之日妊娠期在 24 0/7 至 36 0/7 周之间、年龄≤49 岁、无并发症的单胎妊娠且无已知并发症风险增加的女性。
- 确认艾滋病毒病情稳定。
- 入组前至少 90 天当前且稳定地使用抗逆转录病毒治疗 (ART)。
- 妊娠≥18周时进行胎儿异常超声检查，未观察到明显的胎儿异常。
- 有意在可以获得研究程序的医院或分娩机构分娩。
- 参与者愿意给予参与者的婴儿参与研究的知情同意。
- 能够签署知情同意书，其中包括遵守知情同意文件 (ICD) 和本方案中列出的要求和限制。
主要纳入标准 - 婴儿参与者
- 由父母/法定监护人签名并注明日期的 ICD 证据。
- 家长/法定监护人愿意并且能够遵守预定的访视、研究计划、实验室测试和其他研究程序
主要排除标准 - 母亲参与者
- 孕前体重指数 (BMI) >40 kg/m2 。 如果无法获得孕前 BMI，则可以使用当前怀孕期间第一次产科就诊时的 BMI。
- 患有机会性感染或恶性肿瘤的参与者。
- 入组前 6 个月内有活动性慢性病毒性肝炎病史，且生化证据显示天冬氨酸转氨酶 (AST) 或丙氨酸转氨酶 (ALT) 值 > 正常上限的 5 倍。
- 与疫苗相关的严重不良反应史和/或对研究干预的任何成分或任何相关疫苗的严重过敏反应（例如过敏反应）。
- 目前通过体外受精怀孕。 已知曾使用克罗米芬柠檬酸盐和/或来曲唑并进行或未进行宫内人工授精 (IUI) 的参与者都是允许的。
- 同意时当前的妊娠并发症或异常会增加参与和完成研究的相关风险，包括但不限于以下情况：
- 先兆子痫、子痫或未控制的妊娠期高血压。
- 胎盘异常。
- 羊水过多或羊水过少。
- 严重出血或凝血障碍。
- 内分泌失调，包括未经治疗的甲状腺功能亢进症或未经治疗的甲状腺功能减退症。 这还包括怀孕前或怀孕期间发生的葡萄糖不耐受疾病（例如 1 型或 2 型糖尿病），如果在同意时未得到控制的话。
- 当前妊娠有任何早产迹象，或当前妊娠正在进行干预（医疗/手术）以预防早产。
- 根据研究者的判断，同意时的既往妊娠并发症或异常会增加参与和完成研究的相关风险，包括但不限于以下情况：
- 妊娠≤34周时曾有过早产史
- 既往死产或新生儿死亡
- 以前患有已知遗传性疾病或明显先天异常的婴儿
- 非艾滋病毒相关的先天性或获得性免疫缺陷病，或风湿病或其他需要使用已知免疫抑制剂药物长期治疗的疾病。
- 当前或当前怀孕期间的任何时间使用抗结核治疗。
主要排除标准 - 婴儿参与者
• 婴儿是直接参与研究进行的研究者现场工作人员或申办者和申办者代表雇员的直系后裔（例如子女或孙子女）。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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安慰剂
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实验性的：RSVpreF 疫苗
RSV 疫苗 (RSVpreF)
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RSVpreF 疫苗
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination
大体时间：From Day 1 to Day 7 after vaccination
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Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary).
Redness and swelling were measured by the maternal participant and recorded in measuring device units (mdu) in the e-diary (range: 1 to 21). 1 mdu = 0.5 centimetre (cm).
Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling).
Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for severe pain at the injection site).
Grade 4 reactions were classified by the investigator or medically qualified designee.
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From Day 1 to Day 7 after vaccination
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Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination
大体时间：From Day 1 to Day 7 after vaccination
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Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in the e-diary.
Fever was defined as an oral temperature greater than or equal to (>=) 38.0 degree Celsius (C) and classified as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C) and grade 4 (>40.0
degree C).
Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity).
Vomiting: mild (1-2 times in 24 hours [H]), moderate (>2 times in 24 H), severe (required intravenous [IV] hydration).
Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (>=6 loose stools in 24 H).
For all systemic events except fever, Grade 4= emergency room visit or hospitalization.
Grade 4 events were classified by investigator or medically qualified designee.
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From Day 1 to Day 7 after vaccination
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Percentage of Maternal Participants With Adverse Events (AEs) From the Time of Vaccination Through 1 Month After Vaccination
大体时间：From vaccination on Day 1 up to 1 month after vaccination
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An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Only AEs collected by non-systematic assessment (i.e.
excluding local reactions and systemic events) were included in this outcome measure.
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From vaccination on Day 1 up to 1 month after vaccination
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Percentage of Maternal Participants With Adverse Event of Special Interest (AESIs)
大体时间：From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
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AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study.
AESIs were based on targeted medical events associated with pregnant maternal participants prior to/during delivery and post delivery.
For maternal participants, the following were considered as protocol defined AESIs: diagnosis of Guillain-Barré syndrome; diagnosis of acute polyneuropathy without an underlying etiology; hypertensive disorders of pregnancy; preterm delivery (delivery at <37 0/7 weeks' gestation) and atrial fibrillation.
AESIs was to be recorded as an AE or serious adverse event (SAE) on the case report form (CRF).
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From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
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Percentage of Maternal Participants With SAEs From Vaccination Throughout the Study
大体时间：From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
|
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.
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From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
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Percentage of Infant Participants With AESIs From Birth Through 6 Months of Age
大体时间：From birth up to 6 months of age
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AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study.
AESIs were based on targeted medical events associated with infants at birth.
For infant participants the following were considered as protocol defined AESIs: preterm birth (born at <37 0/7 week's gestation); birth weight 1001-2500 grams (g); developmental delay.
Extremely preterm birth (born at <28 0/7 week's gestation) and extremely low birth weight (less than or equal to [<=] 1000 g) were reported as serious AESIs.
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From birth up to 6 months of age
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Number of Infant Participants With Reported Neonatal Deaths From Birth Through 1 Months of Age
大体时间：Within 1 Month after birth
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Neonatal death was defined as the death of a live-born infant that occurred within a month after birth.
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Within 1 Month after birth
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Number of Infant Participants With Congenital Malformations/Anomalies at Birth
大体时间：At birth
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Congenital malformations/anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life.
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At birth
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Number of Infant Participants With Other Neonatal Problems at Birth
大体时间：At birth
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Other neonatal problem included dysmaturity, neonatal illness, hospitalization, and drug therapies.
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At birth
|
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Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth
大体时间：1 minute after birth
|
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health.
APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing).
Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health.
A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
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1 minute after birth
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Number of Infant Participants According to APGAR Score at 5 Minutes After Birth
大体时间：5 minutes after birth
|
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health.
APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing).
Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health.
A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
|
5 minutes after birth
|
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Number of Infant Participants According to APGAR Score at 10 Minutes After Birth
大体时间：10 minutes after birth
|
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health.
APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing).
Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health.
A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
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10 minutes after birth
|
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Number of Infant Participants According to Gestational Age (GA) at Birth
大体时间：At birth
|
GA at birth was collected as:>=24 to <28 weeks, >=28 to <34 weeks, >=34 to <37 weeks, >=37 to <42 weeks, and >=42 weeks.
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At birth
|
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Number of Infant Participants Requiring Hospitalization at Birth
大体时间：From birth until discharge from hospitalization (up to a maximum of 72 hours)
|
Length of hospitalization at birth refers to the amount of time the infant remains admitted to the healthcare facility immediately following delivery and if that length of time is greater than or less than 72 hours.
Postnatal standard of care procedures in South Africa were as follows: healthy newborns and their mothers were typically discharged within 24 hours after an uncomplicated vaginal delivery, or within 72 hours following an uncomplicated Caesarean section.
These practices were supported by the Guidelines for Maternity Care in South Africa.
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From birth until discharge from hospitalization (up to a maximum of 72 hours)
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Percentage of Infant Participants With AEs From Birth to 1 Month of Age
大体时间：From birth to 1 month of age
|
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
|
From birth to 1 month of age
|
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Percentage of Infant Participants With SAEs From Birth Through 6 Months of Age
大体时间：From birth to 6 months of age
|
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.
|
From birth to 6 months of age
|
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Percentage of Infant Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age
大体时间：From birth to 6 months of age
|
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
NDCMCs were reported as both AEs and SAEs.
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From birth to 6 months of age
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Geometric Mean Titer (GMT) of Neutralizing Titer (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Before Vaccination and at Delivery: Maternal Participants
大体时间：Before vaccination on Day 1 and at delivery
|
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the neutralizing titers and the corresponding CIs based on the Student t distribution.
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Before vaccination on Day 1 and at delivery
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Geometric Mean Fold Rise (GMFR) of NTs for RSV A and RSV B From Before Vaccination to Delivery: Maternal Participants
大体时间：Before vaccination on Day 1 to delivery
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GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs based on the Student t distribution.
The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from the specified time points.
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Before vaccination on Day 1 to delivery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年3月12日
初级完成 (实际的)
2025年6月11日
研究完成 (实际的)
2025年6月11日
研究注册日期
首次提交
2024年3月8日
首先提交符合 QC 标准的
2024年3月19日
首次发布 (实际的)
2024年3月22日
研究记录更新
最后更新发布 (实际的)
2026年7月2日
上次提交的符合 QC 标准的更新
2026年6月30日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
辉瑞将提供对个人去识别化参与者数据和相关研究文件（例如，
根据合格研究人员的要求，并遵守某些标准、条件和例外情况，提供协议、统计分析计划 (SAP)、临床研究报告 (CSR)。
有关辉瑞数据共享标准和请求访问流程的更多详细信息，请访问：https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests。
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.