Prevention for Mother-to-infant Transmission of HBV

HBV Clinical Trial

Official title:

HBIG for Prevention of Mother-to-infant HBV Transmission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312531
• Other study ID #: 2012ZX10002007-001-001 -1
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: December 8, 2014
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Xi’an Jiaotong University College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In this study, HBV-infected pregnant women were divided into two groups, those who received and those who did not receive hepatitis B immunoglobulin (HBIG) during pregnancy. In the mothers, the changes in HBV serum markers (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), HBeAg, hepatitis B core antibody (HBcAb)), and the DNA load were investigated. Immunohistochemical staining with custom-made antibodies against HBIG revealed both the level and distribution of HBIG in placentas. The protective mechanism of HBIG administrated during pregnancy was explored.

Description:

Twenty-eight HBsAg-positive pregnant women who underwent consultation were recruited from the First Affiliated Hospital of Xi'an Jiaotong University, Shaanxi, China. Twelve of these women willing to receive HBIG administration were assigned to experimental group, while another sixteen without HBIG injection were enrolled as control group. The exclusion criteria for participants were: 1) infection with toxoplasmosis, syphilis, parvovirus B19, rubella, cytomegalovirus, herpes, hepatitis C, HIV, or other viruses; 2) obstetric diseases such as pregnancy-related hypertension, placental abruption, threatened miscarriage, and others.

The 12 pregnant women enrolled willing to receive injections of HBIG (200 IU, S20023028, Hualan Biological Engineering Inc.) beginning at week 20 of gestation (at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40). The control group only underwent regular examinations without any HBIG treatment during pregnancy. All the infants born received combined immunoprophylaxis (HBIG, 200 IU, and the first dose of the hepatitis B vaccine, 5 μg, S19983018, Shenzhen Kangtai Biological Products Co. Ltd.) at different injection sites within 12 h postpartum.

Data of mothers were collected from medical records that included complete healthcare information before and after delivery. Each infant was consecutively followed up after birth, growth index (weight, length and head circumference), feeding patterns and serum level of HBV DNA and viral markers were recorded. Serum HBV markers (HBsAg, HBsAb, HBeAg, and HBcAb) titers、HBV DNA load and liver function of mothers were regularly measured during pregnancy. Serum HBsAg, HBsAb titer and HBV DNA load of infants were tested at birth, the age of 7 and 12 months. Placental tissue sections were used for immunohistochemical staining of HBsAg (mouse, 1:50, ZM-0122, Beijing Zhongshan Golden Bridge Biotechnology Co.), HBIG (rabbit, 4.7 mg/ml, 1:2500, prepared as described above), and CD68 (mouse, 1:25, ab955, Abcam).

Adverse outcome, HBV infection rate of infants, HBV markers titers, liver function and HBV DNA load of mothers, correlation between mothers and newborns regarding HBsAb titer and histopathological changes in placenta samples were compared between experimental group and control group.

Statistical analysis was performed using SPSS 13.0 statistical software (SPSS Inc., Chicago, USA). Data were expressed as the mean ± standard deviation (SD). The data were analyzed with the Shapiro-Wilk test and the Levene statistic for normality and homogeneity of variance, respectively. The difference between two quantitative groups was compared with an independent-sample t-test or the Mann-Whitney U-test as appropriate, and correlations were analyzed with the Pearson or Spearman correlation test. The chi-square test or Fisher's exact test was used to compare the proportions of the two groups. All tests were two-tailed with the risk set at 5%, and the statistical significance was set as p < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HBsAg positive for more than 6 months, gestational age less than 20 weeks

Exclusion Criteria:

• infection with toxoplasmosis, syphilis, parvovirus B19, rubella, cytomegalovirus, herpes, hepatitis C, HIV, or other viruses; obstetric diseases such as pregnancy-related hypertension, placental abruption, threatened miscarriage, and others.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HBV

Intervention

Drug:
• Hepatitis B immunoglobulin
Hepatitis B immunoglobulin 200 IU injection at gestational week 20, 24, 28, 32, 34, 36, 38, 39, and 40 in HBIG group mothers.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xi’an Jiaotong University College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV infection of infants	HBV DNA and HBsAg positive at the age of 1 year old	one year	No
Primary	Histopathological changes in placenta	Immunohistochemical staining of HBsAg, HBIG and CD68	at delivery	No
Secondary	Serum HBV markers titers?HBV DNA load and liver function changes	Serum HBV markers (HBsAg, HBsAb, HBeAg, and HBcAb) titers?HBV DNA load and liver function of mothers were regularly measured.	at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation	No
Secondary	Adverse events	Reports of premature and partum complications, ALT flare, delivery mode and birth defects.	at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation, at delivery, at the age of 7 and 12 months of infants	Yes