Summary Background A vaccine against COVID-19 is urgently needed for older adults, in whom morbidity and mortality due to the disease are increased. We aimed to assess the safety, tolerability, and immunogenicity of a candidate COVID-19 vaccine, CoronaVac, containing inactivated SARS-CoV-2, in adults aged 60 years and older. Methods We did a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial of CoronaVac in healthy adults aged 60 years and older in Renqiu (Hebei, China). Vaccine or placebo was given by intramuscular injection in two doses (days 0 and 28). Phase 1 comprised a dose-escalation study, in which participants were allocated to two blocks: block 1 (3 μg inactivated virus in 0·5 mL of aluminium hydroxide solution per injection) and block 2 (6 μg per injection). Within each block, participants were randomly assigned (2:1) using block randomisation to receive CoronaVac or placebo (aluminium hydroxide solution only). In phase 2, participants were randomly assigned (2:2:2:1) using block randomisation to receive either CoronaVac at 1·5 μg, 3 μg, or 6 μg per dose, or placebo. All participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after each injection in all participants who received at least one dose. The primary immunogenicity endpoint was seroconversion rate at 28 days after the second injection (which was assessed in all participants who had received the two doses of vaccine according to their random assignment, had antibody results available, and did not violate the trial protocol). Seroconversion was defined as a change from seronegative at baseline to seropositive for neutralising antibodies to live SARS-CoV-2 (positive cutoff titre 1/8), or a four-fold titre increase if the participant was seropositive at baseline. This study is ongoing and is registered with ClinicalTrials.gov (NCT04383574). Findings Between May 22 and June 1, 2020, 72 participants (24 in each intervention group and 24 in the placebo group; mean age 65·8 years [SD 4·8]) were enrolled in phase 1, and between June 12 and June 15, 2020, 350 participants were enrolled in phase 2 (100 in each intervention group and 50 in the placebo group; mean age 66·6 years [SD 4·7] in 349 participants). In the safety populations from both phases, any adverse reaction within 28 days after injection occurred in 20 (20%) of 100 participants in the 1·5 μg group, 25 (20%) of 125 in the 3 μg group, 27 (22%) of 123 in the 6 μg group, and 15 (21%) of 73 in the placebo group. All adverse reactions were mild or moderate in severity and injection site pain (39 [9%] of 421 participants) was the most frequently reported event. As of Aug 28, 2020, eight serious adverse events, considered unrelated to vaccination, have been reported by seven (2%) participants. In phase 1, seroconversion after the second dose was observed in 24 of 24 participants (100·0% [95% CI 85·8–100·0]) in the 3 μg group and 22 of 23 (95·7% [78·1–99·9]) in the 6 μg group. In phase 2, seroconversion was seen in 88 of 97 participants in the 1·5 μg group (90·7% [83·1–95·7]), 96 of 98 in the 3 μg group (98·0% [92·8–99·8]), and 97 of 98 (99·0% [94·5–100·0]) in the 6 μg group. There were no detectable antibody responses in the placebo groups. Interpretation CoronaVac is safe and well tolerated in older adults. Neutralising antibody titres induced by the 3 μg dose were similar to those of the 6 μg dose, and higher than those of the 1·5 μg dose, supporting the use of the 3 μg dose CoronaVac in phase 3 trials to assess protection against COVID-19. Funding Chinese National Key Research and Development Program and Beijing Science and Technology Program.

Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial.

David R. Hill, Charles D. Ericsson, Richard D. Pearson, Jay S. Keystone, David O. Freedman, Phyllis E. Kozarsky, Herbert L. DuPont, Frank J. Bia, Philip R. Fischer, and Edward T. Ryan National Travel Health Network and Centre and Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, England; Department of Medicine, University of Toronto, and Center for Travel and Tropical Medicine, Toronto General Hospital, Toronto, Ontario, Canada; Department of Internal Medicine, Clinical Infectious Diseases, University of Texas Medical School at Houston, Department of Internal Medicine, St. Luke’s Hospital, and Center for Infectious Diseases, University of Texas at Houston School of Public Health, and Department of Medicine, Baylor College of Medicine, Houston, Texas; Departments of Medicine and Pathology, Division of Infectious Diseases and International Health, University of Virginia School of Medicine, Charlottesville, Virginia; Departments of Medicine and Epidemiology, Division of Geographic Medicine, University of Alabama at Birmingham, Birmingham; Department of Medicine, Infectious Diseases, Emory University School of Medicine, and 16 Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, Atlanta, Georgia; Department of Medicine and Laboratory Medicine, Yale Medical School, New Haven, Connecticut; Department of Pediatrics, Division of General Pediatric and Adolescent Medicine, Mayo Clinic College of Medicine, and Mayo Eugenio Litta Children’s Hospital, Mayo Clinic, Rochester, Minnesota; and Department of Medicine, Division of Infectious Diseases, Harvard Medical School, Harvard School of Public Health, and Tropical and Geographic Medicine Center, Massachusetts General Hospital, Boston, Massachusetts

https://www.uphs.upenn.edu/bugdrug/antibiotic_manual/idsatravelmed.pdf

The practice of travel medicine: guidelines by the Infectious Diseases Society of America.

The role of mobile phones in improving vaccination rates in travelers.

Table of contents 1.0 Introduction 1.1 General principles of immunization in HIVinfected adults 1.2 Practical aspects of immunization and general contraindication 2.0 Anthrax 2.1 Background 2.2 Epidemiology and risk groups 2.3 Anthrax vaccine 2.3.1 Vaccine efficacy 2.3.2 Vaccine safety 2.4 Recommendations for anthrax pre-exposure prophylaxis in HIV-infected adults 2.5 Post-exposure prophylaxis 3.0 Cholera 3.1 Background 3.2 Epidemiology and risk groups 3.3 Cholera vaccine 3.3.1 Vaccine efficacy 3.3.2 Vaccine safety 3.3.3 Contraindications 3.4 Recommendations for cholera pre-exposure prophylaxis in HIV-infected adults 4.0 Diphtheria 4.1 Background 4.2 Epidemiology and risk groups 4.3 Diphtheria vaccine 4.3.1 Vaccine efficacy 4.3.2 Vaccine safety 4.4 Recommendations for diphtheria pre-exposure prophylaxis in HIV-infected adults 4.5 Post-exposure prophylaxis 4.6 Auditable outcomes 5.0 Haemophilus influenzae serotype b 5.1 Background 5.2 Epidemiology and risk groups 5.3 Hib vaccine 5.3.1 Vaccine efficacy 5.3.2 Vaccine safety 5.4 Recommendations for H. influenzae pre-exposure prophylaxis in HIV-infected adults 5.5 Post-exposure prophylaxis 5.6 Auditable outcomes 6.0 Hepatitis A 6.1 Background 6.2 Epidemiology and risk groups 6.3 Hepatitis A vaccine 6.3.1 Vaccine efficacy 6.3.2 Vaccine safety 6.4 Human normal immunoglobulin 6.5 Recommendations for hepatitis A pre-exposure prophylaxis in HIV-infected adults 6.6 Post-exposure prophylaxis 6.7 Recommendations for hepatitis A post-exposure prophylaxis in HIV-infected adults 6.8 Auditable outcomes 7.0 Hepatitis B 7.1 Background 7.2 Epidemiology and risk groups 7.3 Hepatitis B vaccine 7.3.1 Vaccine efficacy 7.3.2 Vaccine safety 7.4 Recommendations for hepatitis B pre-exposure prophylaxis in HIV-infected adults 7.5 Post-exposure prophylaxis *Anna Maria Geretti, Royal Free Hospital, London; Gary Brook, Central Middlesex Hospital, London; Claire Cameron, Health Protection Agency, Colindale; David Chadwick, James Cook University Hospital, Middlesbrough; Robert S Heyderman, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi; Eithne MacMahon, Guy’s and St Thomas’ NHS Foundation Trust, London; Anton Pozniak, Chelsea and Westminster Hospital, London; Mary Ramsay, Health Protection Agency, Colindale; M Schuhwerk, Mortimer Market Centre, London.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1468-1293.2008.00637.x

British HIV Association guidelines for immunization of HIV-infected adults 2008.

HEPATITIS A IS A VACCINE-PREVENTABLE, COMMUNICABLE DISEASE OF THE LIVER CAUSED BY THE HEPATITIS A VIRUS (HAV). THE INFECTION IS TRANSMITTED VIA THE FECAL-ORAL ROUTE, USUALLY FROM DIRECT PERSON-TO-PERSON CONTACT OR CONSUMPTION OF CONTAMINATED FOOD OR WATER. HEPATITIS A IS AN ACUTE, SELF-LIMITED DISEASE THAT DOES NOT RESULT IN CHRONIC INFECTION. HAV ANTIBODIES (IMMUNOGLOBULIN G [IGG] ANTI-HAV) PRODUCED IN RESPONSE TO HAV INFECTION PERSIST FOR LIFE AND PROTECT AGAINST REINFECTION; IGG ANTI-HAV PRODUCED AFTER VACCINATION CONFER LONG-TERM IMMUNITY. THIS REPORT SUPPLANTS AND SUMMARIZES PREVIOUSLY PUBLISHED RECOMMENDATIONS FROM THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) REGARDING THE PREVENTION OF HAV INFECTION IN THE UNITED STATES. ACIP RECOMMENDS ROUTINE VACCINATION OF CHILDREN AGED 12-23 MONTHS AND CATCH-UP VACCINATION FOR CHILDREN AND ADOLESCENTS AGED 2-18 YEARS WHO HAVE NOT PREVIOUSLY RECEIVED HEPATITIS A (HEPA) VACCINE AT ANY AGE. ACIP RECOMMENDS HEPA VACCINATION FOR ADULTS AT RISK FOR HAV INFECTION OR SEVERE DISEASE FROM HAV INFECTION AND FOR ADULTS REQUESTING PROTECTION AGAINST HAV WITHOUT ACKNOWLEDGMENT OF A RISK FACTOR. THESE RECOMMENDATIONS ALSO PROVIDE GUIDANCE FOR VACCINATION BEFORE TRAVEL, FOR POSTEXPOSURE PROPHYLAXIS, IN SETTINGS PROVIDING SERVICES TO ADULTS, AND DURING OUTBREAKS.

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Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020.

A new accelerated vaccination schedule for rapid protection against hepatitis A and B

Rapid protection against hepatitis A and hepatitis B following an accelerated schedule of a combined hepatitis A/B vaccine

Serological investigations (immunoglobulin, haptoglobin, cryoglobulin, and antibody determination against Plasmodium falciparum and P. malariae antigens) were performed in 64 adults of the Albert-Schweitzer-Hospital, Lambarene, Gabon. The patients were referred consecutively for ultrasound examination of the upper abdominal tract. 31 patients had clinically and sonographically an enlarged spleen, whereas 34 had a normal-sized spleen. 18 patients were regarded as having a gross splenomegaly without an obvious underlying cause (tropical splenomegaly (TSS]. No significant differences were seen between the patient groups with regard to immunoglobulin M or antiplasmodial antibody concentration. Thus, a causal association of splenomegaly with chronic malaria infections could not be established. The haptoglobin levels were significantly (P less than 0.01) reduced in patients with splenomegaly. Peripheral T-lymphocyte subsets as defined by monoclonal antibodies showed in all 4 cases with gross splenomegaly examined distinct abnormalities. Tropical splenomegaly is thought to encompass a variety of diseases, most of them presenting an intermediate stage of reactive to autonome disorders of the lymphatic system.

M Dietrich

Papers

A new accelerated vaccination schedule for rapid protection against hepatitis A and B

Rapid protection against hepatitis A and hepatitis B following an accelerated schedule of a combined hepatitis A/B vaccine

Serological and immunological investigations in patients with gross splenomegaly from the Gabon.