Μg Of Hepatitis Research Articles

Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial

ABSTRACT Objectives The immunogenicity of hepatitis B vaccine is unsatisfactory in the people living with HIV (PLHIV). Studies evaluating optimal regimens to enhance immunogenicity have heretofore been inconclusive. The study was to compare the immunogenicity and safety of the four standard-dose and high-dose regimens of hepatitis B vaccine among PLHIV. Methods A randomized, parallel-controlled trial was conducted between May, 2020, and January, 2021. Patients were randomly assigned to receive 3 or 4 doses of 20 or 60 µg of hepatitis B vaccine. Seroconversion rate, high-level response rate, and geometric mean concentration (GMC) of antibody to hepatitis B surface antigen (anti-HBs) at weeks 12 and 28 were the main outcome measures. Results At week 28, the seroconversion rate and GMC of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than those in the IM20 × 3 group (P < 0.05), and the GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group. Conclusions In PLHIV, both the four standard-dose and high-dose regimens significantly improved immunogenicity. The GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group. Clinical trial registration ClinicalTrials.gov (NCT03962803)

Effect of methylprednisolone injection on interleukin-4 and interferon-gamma expression following hepatitis B vaccination in mice.

The prevalence of hepatitis B infection is high worldwide with liver cirrhosis and hepatocellular carcinoma as important complications. Immunosuppression, especially from corticosteroids, is often cited as a cause of poor immune response and there is documented evidence of irrational administration of glucocorticoids to children and adults. Decreased expression of interleukin-4 and interferon-gamma is an indication of poor humoral and cellular immune responses, respectively. Therefore, we decided to find out if methylprednisolone injection decreases interleukin-4 and interferon-gamma expression following hepatitis B vaccination in mice. Mice were randomly divided into 2 groups. Daily intramuscular injections of methylprednisolone (15 mg/kg) were given to the test group while water for injection (0.1 mL) was given to the control group for 30 days. On day 6 all mice were given 2 μg of hepatitis B vaccine and they received a booster dose on day 27. On day 34, blood samples were collected and analyzed for interleukin-4 and interferon-gamma titers. There was positive interleukin-4 and interferon-gamma response in all groups but the differences in titers were not statistically significant. At the dosages and length of exposure used in this study, methylprednisolone injection did not significantly inhibit interleukin-4 and interferon-gamma expression following immunization against hepatitis B virus in mice.

Long-term follow-up of antibody titers after hepatitis A vaccination

To evaluate the potential long-term efficacy of hepatitis A vaccination for prevention of hepatitis A virus(HAV) infection, anti-HAV titers in serum were measured serially. Twelve anti-HAV-negative volunteers were injected with 0.25, 0.5 or 1.0, μg of hepatitis A vaccine at time zero, 1 and 6 months, and anti-HAV titers were monitored over a 54-month interval after the first injection. In addition, another 33 volunteers were injected with 0.5, μg of hepatitis A vaccine at time zero and 2 weeks, and anti-HAV titers were measured until 18 months. All the volunteers given two or three vaccinations seroconverted to anti-HAV by 1 month after the second injection. In subjects undergoing three injections, all remained anti-HAV positive during the observation period and the geometric mean titers (GMTs) were greater than 100 mIU/ml. In subjects undergoing two injections, anti-HAV remained positive until 18 months after the first vaccination. We therefore conclude that the hepatitis A vaccine induces a sustained anti-HAV antibody titer.

The Safety and Immunogenicity of a Human Immunodeficiency Virus Type 1 (HIV-1) Recombinant gp160 Candidate Vaccine in Humans

To evaluate the safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant envelope glycoprotein (rgp 160) candidate vaccine in humans. Healthy adults (72) who were seronegative for HIV-1 were randomly assigned to one of four groups. The subjects were randomly assigned to receive 40 or 80 micrograms of rgp 160, 10 micrograms of hepatitis B vaccine, or placebo in three doses (on days 0, 30, and 180), with an elective, nonblinded administration of a fourth dose on day 540. Neither clinical nor laboratory toxicity was encountered during a follow-up period exceeding 21 months. No effect of immunization was noted on lymphocyte counts, mitogenic responses, or delayed-type hypersensitivity. Serum antibody responses to HIV envelope proteins detected by Western blot were seen in 30 of 33 subjects (91%; 95% CI, 71% to 97%) receiving either 40- or 80-micrograms doses of rgp160 and were most commonly of weakly reactive intensity. Responses were first noted by Western blot after the second dose. They markedly increased in frequency after the third dose and declined over the next 12 to 18 months. The administration of a fourth dose resulted in homologous neutralizing activity in sera from 5 to 24 subjects (21%; CI, 7% to 37%) as well as in complement-mediated antibody-dependent enhancement in sera from 6 of 24 subjects (25%; CI, 10% to 42%). Antibody responses were detected by enzyme-linked immunosorbent assay (ELISA) less frequently than by Western blot, and these responses persisted for a shorter time. The administration of rgp160 was well tolerated and safe, resulted in a high rate of antibody response by Western blot after the administration of the third and fourth doses, and generated serum neutralizing activity and complement-mediated antibody-dependent enhancement in some subjects after the fourth dose.

Low-Dose Intradermal Hepatitis B Vaccine

To the Editor.— In a recent report from the Walter Reed Army Institute of Research, Redfield and colleagues 1 presented the results of a study in which 2 μg of hepatitis B vaccine administered intradermally (ID) to 25 health workers was compared with the standard 20-μg dose administered intramuscularly (IM) to another 25 health workers. Based on similar seroconversion rates and antibody levels achieved, these investigators concluded that the low-dose ID regimen was comparable in immunogenicity with the IM regimen. Obviously, if ID administration requires one-tenth the dose of the IM route, the potential savings in vaccine costs would make this vaccine more affordable and, therefore, more available than it is now. For the military, already under budgetary pressure to limit spending, the dollar savings for a mass vaccination program of military personnel rotating for brief tours of duty through high-risk areas of the world would be substantial. On the

Low-dose intradermal hepatitis B vaccine

<h3>To the Editor.—</h3> In a recent report from the Walter Reed Army Institute of Research, Redfield and colleagues¹presented the results of a study in which 2 μg of hepatitis B vaccine administered intradermally (ID) to 25 health workers was compared with the standard 20-μg dose administered intramuscularly (IM) to another 25 health workers. Based on similar seroconversion rates and antibody levels achieved, these investigators concluded that the low-dose ID regimen was comparable in immunogenicity with the IM regimen. Obviously, if ID administration requires one-tenth the dose of the IM route, the potential savings in vaccine costs would make this vaccine more affordable and, therefore, more available than it is now. For the military, already under budgetary pressure to limit spending, the dollar savings for a mass vaccination program of military personnel rotating for brief tours of duty through high-risk areas of the world would be substantial. On the