Clinical trial of a lyophilized inactivated hepatitis A candidate vaccine in healthy adult volunteers.

The safety and immunogenicity of a lyophilized inactivated hepatitis A vaccine was tested in healthy adult male volunteers. Thirty-six volunteers, all of whom were negative for antibody to HAV (anti-HAV), were divided into three dosage groups, 1.0, 0.5 and 0.25 micrograms of viral protein, respectively. Each group received a total course of three intramuscular injections at months 0, 1 and 6. Slight side effects were noted after 16 of 99 injections and the occurrence and degree were almost identical to those of other commercial vaccines. On the other hand, all subjects had measurable titres of serum anti-HAV neutralizing antibodies as early as 2 months after the first injection. The mean values of serum anti-HAV neutralizing antibodies at 7 months in the 1.0, 0.5 and 0.25 micrograms dose groups were 64-, 12-, and 9-fold higher, respectively, than those observed at 5 days in five recipients given 7.5 mg kg-1 body weight of immune serum globulin (ISG).

[Clinical courses and pathological findings in two gay male patients with acquired immunodeficiency syndrome infected in Japan].

This is a report on the clinical courses and pathological findings in two gay male patients with acquired immunodeficiency syndrome (AIDS) infected in Japan. Case 1. A 39 year-old Japanese homosexual male was diagnosed as amebic dysentery complicated with liver abscess on admission. He was placed on Metronidazole with complete relief. Serological tests was positive for AIDS. On second admission, he was found to have pneumocystis carinii pneumonia (PCP) and cytomegalo-viral uveitis. Administration of Pentamidine was partially effective, however the therapy with Azidothimidine was discontinued by bone marrow suppression. On his third admission, he suffered from cryptococcal meningitis and therapy-resistant fungusemia. Finally he died of recurrent pneumonia regardless of appropriate therapies. Autopsy proved extended cryptococcal infection in the brain, meninx, lungs, liver and kidney, and cytomegalo-infection in the lungs, liver and kidney. Furthermore, atypical mycobacteriosis was found in the lymph nodes. There was no active findings compatible with PCP. Case 2. A 44 year-old Japanese homosexual male was admitted with oral candidiasis and diagnosed as AIDS related complex. He suffered from pneumonia with marked improvement on sulfamethoxazole-Trimethoprim. On his second admission, he developed diarrhea and was found to be infected with Giardia lambia. In addition, cytomegalo-viral infection damaged his eye sight. He died of pneumonia and meningitis shortly there after. Autopsy proved a cytomegalo-viral infection in the lung and colon, old lesions possibly caused by PCP in the lungs, and suppurative meningitis in the meninx. These experiences confirm that AIDS patients can be exposed to several opportunistic infections at the same time in the multiple organs. Furthermore, it is suggested that homosexual patients with AIDS may have unique opportunistic infections such as amebic dysentery or Giardia lamblia unlike other AIDS patients related to hemophilia.

[Fundamental and clinical investigation of clindamycin-2-phosphate in otorhinolaryngological field (author's transl)].

Some laboratory examinations were made with clindamycin-2-phosphate (CLDM-2-phos.). The drug was applied clinically to several otorhinolaryngological infections and the good results were obtained as follows. 1) Observing by biophotometer, the growth of Staphbylococcus aureus FDA 209P was inhibited well by the serum (diluted 10-fold) 30 minutes, 1, 2, 4 hours after 300 mg of CLDM-2-PHOS. were injected intramuscularly. 2) Serum concentration was determined by thin-layer method with Sarcina lutea ATCC 9341 as the test organism. The peak of serum level was obtained at 1 hour after a single intramuscular injection of 5 mg/kg or 10 mg/kg dosis of CLDM-2-phosphate. The peak of blood concentration was 5.4 mug/ml, 5.6 mug/ml respectively. 3) CLDM-2-phosphate concentration in tissues was estimated one hour after intramuscular injection of CLDM-2-Phosphate. The concentrations in blood and palatine tonsilla were 5.0 mug/ml and 2.9 mug/ml respectively after the intramuscular injection of 10 mg/kg. The concentrations in blood and mucous membrane of maxillar sinusitis were 4.1 mug/ml and 2.5 mug/ml respectively after the intramuscular injection of 10 mg/kg. 4) CLDM-2-phosphate was administered by intramuscular injection into 30 cases with various infections in otorhinolaryngological field. The clinical results were excellent in 22 cases (73.3%), effective in 3 cases (10.0%) and ineffective in 5 cases (16.7%). The effectiveness was 83.3%. 5) No side effects were observed in 30 cases.